Kornimate/medical-research-clean huggingface dataset:
a study of jnj-77242113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of the hands and the soles of the feet)

Conditions: Plaque Psoriasis

Summary: the purpose of the study is to see how effective jnj-77242113 is in participants with plaque psoriasis affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet).


Eligibility criteria:
inclusion criteria: * diagnosis of plaque psoriasis, with or without psoriatic arthritis (psa), for at least 26 weeks prior to the first administration of study intervention * candidate for phototherapy or systemic treatment for plaque psoriasis * need to meet criteria: total body surface area (bsa) greater than or equal to (\>=)1 percent (%) at screening and baseline, and investigator global assessment (iga) (overall) \>=2 at screening and baseline and at least one of the following: scalp-specific investigator global assessment (ss-iga) score \>=3 at screening and baseline, and/or static physician's global assessment of genitalia (spga-g) \>=3 at screening and baseline, and/or physician's global assessment of hands and feet (hf-pga) score \>=3 at screening and baseline * failed to respond to at least 1 topical therapy (example, corticosteroids, calcineurin inhibitors, and/or vitamin d analogs) used for treatment of psoriasis * confirmation of plaque psoriasis in a non-special area (example, areas excluding scalp, genital, palmoplantar) at screening and baseline exclusion criteria: * nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) * dermatoses other than plaque psoriasis (such as contact dermatitis) or palmoplantar pustulosis of the palmoplantar area (if hf-pga \>=3 at baseline) * current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * known allergies, hypersensitivity, or intolerance to jnj-77242113 or its excipients
using a sheathed speculum to visualize and access the cervix in women with excessive vaginal tissue

Conditions: Vaginal Prolapse

Summary: the main objective of the study is to assess the effectiveness of the sheathed speculum in providing adequate visualization and access to the cervix in patients with excessive vaginal tissue. the secondary objective is to rate the patient's comfort evaluation during the sheathed speculum examination.

this is a descriptive clinical trial designed to assess the efficacy of a sheathed speculum in providing adequate visualization and access to the cervix in women with excessive vaginal tissue. eligible, consented subjects who fail their initial speculum examination (because their cervix is not visualized due to the collapse of loose lateral vaginal walls) will have a sheathed speculum examination instead of the standard-of-care exam whereby the clinician fabricates a solution at the bedside (condom with tip cut placed on speculum, concomitantly using an additional instrument like a lateral-wall retractor, glove with tip of thumb placed over the speculum, using the largest speculum available)

Eligibility criteria:
inclusion criteria: * age 18 to 64 years * bmi greater than 30 (or see next line) * collapsing vaginal tissue preventing the visualization of the cervix (meeting this criterion in the absence of a bmi \>30 would also qualify the patient for the study). * able to provide written informed consent exclusion criteria: * patients unwilling to participate in the study or provide consent presence of significant acute pelvic pain syndromes (ie exacerbation of dyspareunia, chronic pelvic pain or pelvic floor dysfunction, atrophic vaginitis, interstitial cystitis, endometriosis) which, in the opinion of the examining clinician, could potentially confound the patient's responses to the questionnaire * presence of active genital herpes * presence of significant condyloma acuminata (may be an investigator decision) * any other patient deemed inappropriate for the study by the consenting or examining investigator.
evaluate the safety and performance of dura sealant patch in reducing csf leakage following elective cranial surgery

Conditions: Cerebrospinal Fluid Leak

Summary: the objective of the study is to clinically assess the safety and performance of the dura sealant patch as a means of reducing intra- as well as post-operative csf leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.


Eligibility criteria:
inclusion criteria: preoperative subjects who are able to provide a written informed consent prior to participating in the clinical investigation. subjects who are ≥ 18 years old. subjects who are able to comply with the follow-up or other study requirements. subjects who are planned for an elective intracranial intradural surgery in whom a dural incision of at least 2 cm in length is necessary, which will be closed. female subjects of child bearing potential must agree to use any form of contraception from the time of signing the informed consent form through 90 days post-surgery. intraoperative surgical wound classification class i/clean. minimally 5 mm of dural space surrounding dural opening. exclusion criteria: preoperative female subjects who are pregnant or breastfeeding. subjects with an assumed impaired coagulation due to medication or otherwise. subjects suspected of an infection requiring antibiotics. subjects with any type of dural diseases in planned dural closure area. subjects requiring re-opening of planned surgical area within 90 days after surgery. subjects requiring local radiotherapy in planned surgical area. subjects with a known allergy to any of the components of the dura sealant patch. subject who previously participated in this study or any investigational drug or device study within 30 days of screening. subjects with a presence of hydrocephalus. intraoperative subjects in whom elevation of peep or pco2 has a potential detrimental effect. subjects who will require a csf or wound drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery. primary closure of the dura mater with synthetic, non-autologous or autologous material other than galea. a gap \> 3 mm after primary closure of the dura mater.
prospective randomized clinical trial assessing the short term clinical impact of continuous vs flash glucose monitoring in children, adolescents and young adults with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: impaired hypoglycemia awareness, a significant problem for children with type 1 diabetes, is defined as neurogenic symptom response before autonomic response to hypoglycemia. avoiding hypoglycemia appears to restore hypoglycemia awareness. investigators have previously demonstrated in a retrospective study that flash glucose monitoring system decreased the risk of severe hypoglycemia in type 1 diabetic children and adolescents, even though flash glucose monitoring system, unlike continuous glucose monitoring system, does not provide glucose alerts. continuous glucose monitoring system, by providing real-time data with alarms, could benefit to subjects still experiencing severe hypoglycemia with flash glucose monitoring system. besides, in adults, continuous glucose monitoring system reduced more effectively impaired hypoglycemia awareness compared to flash glucose monitoring system. in that context, investigators would like to assess the impact of continuous glucose monitoring system instead of flash glucose monitoring system on hypoglycemia in children and adolescents with type 1 diabetes.

all subjects will start with a 7 days run-in phase using their current flash glucose monitoring system associated with a blind continuous glucose monitoring system (envision, medtronic). after one week, subjects randomized in the the interventional group will be provided with the continuous glucose monitoring (guardian connect, medtronic) and trained by dedicated diabetes educators for continuous glucose monitoring usage including insertion of the sensor, calibration of the device twice daily and interpretation of the data. subjects will use the sensors according to the license. for both groups, insulin doses decisions are made by the participant according the received education. after one week, all subjects will be contacted by phone focusing on the use of the technology. the treatment period is 8 weeks. the last week of the treatment period, subjects will use the blind continuous glucose monitoring system (envision, medtronic) in addition to their allocated glucose monitoring system.

Eligibility criteria:
inclusion criteria: * male and female aged from 4 to 20 years * subjects with onset of diabetes before 16 years of age * diabetes duration of more than 1 year * subject currently using flash glucose monitoring system in daily practice exclusion criteria: * subject with mental disability * previous use of continuous glucose monitoring system * subject currently participating to another clinical study
a randomized study of intraocular caliper-assisted capsulotomy for age-related cataract patients with corneal limbus opacity

Conditions: Cataract Extraction

Summary: the purpose of this study is to compare the accuracy of capsulotomy assisted by intraocular caliper and verion navigation system in phacoemulsification surgery and postoperative visual quality for age-related cataract patients with corneal limbus opacity.

continuous curvilinear capsulorhexis (ccc) is an important and technically challenging procedure in cataract surgery. too large or too small capsulorhexis can increase the incidence of intraoperative and postoperative complications. in recent years, the image projection device verion navigation system has been reported that it can improve the repeatability and accuracy of capsulorhexis via projecting a pre-set size ring to guide capsulorhexis. however, we found that for the patients with corneal geriatric ring, pterygium or limbal lesions leading to unclear limbal boundary, the projected capsulorhexis will deviate from the center, resulting in capsulorhexis is off center in clinical practice. our self-developed intraocular caliper, which is modified on the conventional intraocular irrigation needle, can accurately measure the size of capsulorhexis, and mark the position and boundary of capsulorhexis on the lens anterior capsule to guide capsulorhexis, thus significantly improves the accuracy and centricity of capsulorhexis. the purpose of this study is to compare the centricity and accuracy of intraocular caliper-assisted capsulorhexis in phacoemulsification for age-related cataract patients with corneal limbus opacity with that of verion projection navigation system.

Eligibility criteria:
inclusion criteria: * adults aged 55 to 80 years with age-related cataract with pterygium, corneal geriatric ring, and corneal limbus opacity; * pupil diameter ≥ 6.5mm after pupil dilation; * lens nuclear opacity grading score (locs iii) lower than 4.0. exclusion criteria: * patients had previous intraocular surgery; * patients with a diagnosed eye disease that may affect the functions of lens suspensory ligament such as previous ocular trauma, lens subluxation, pseudoexfoliation syndrome, retinal pigment degeneration; * patients had other ocular diseases that impair visual function include optic neuropathy, uveitis, and tumor. * refused to participate the study.
community-acquired pneumonia diagnosis using lung ultrasound in emergency room adults

Conditions: Community-acquired Pneumonia

Summary: community-acquired pneumonia (cap) is a major problem in emergency department (ed). diagnosis relies on combination of clinical symptoms and results of chest radiography (cr). patients' management (treatment, support) depends on delay and quality of the diagnosis. however, signs and symptoms are highly aspecific and interpretation of cr is subject to frequent discrepancies. then diagnosis of cap may be uncertain; therefore, overdiagnosis is frequent and leads to over-use of antimicrobial therapy; missing diagnosis is also deleterious and delays adequate treatment including antibiotics. ct scan completes cr and helps clinician making properly diagnosis of cap; obtaining ct in a 4-hour time-lapse allows better diagnosis and management as accurate as an independent expert adjudication committee does. however availability of ct as well as radiation interrogates on the benefit that lung ultrasounds (lus) may have in diagnosis strategy of suspected cap. lus is a noninvasive easy-to-use device whose practice is widely endorsed worldwide by emergency medicine associations and societies. additionally, previous studies advocate for the use of lus for diagnosis of cap in the ed. therefore the promotor developed a study to compare lus and cr as a primary imaging for diagnosis of cap at the ed.


Eligibility criteria:
inclusion criteria: * adult patients (18+) * suspected cap by attending emergency physician * and new onset of systemic infection (at least one among sweat, chills, aches and pain, temperature ≥38°c or \<36°c) * and symptoms of an acute lower respiratory tract infection (at least one among cough, sputum production, dyspnea, chest pain, altered breathing sounds at auscultation * no previous imaging for the current medical problem * inform consent (signed) * affiliation to insurance (france, monaco) exclusion criteria: * age below 18-year of age * patients in palliative care * pregnant women * anticipated barriers to completing follow-up data collection, * patients classified three or higher according to the crb65 score, * patients requiring intensive care for any purpose because of specific management of critically ill * refusal to participate to the study
prevention of contrast induced nephropathy by erythropoietin

Conditions: Diabetes; Chronic Kidney Insufficiency

Summary: this ia a prospective, randomized, double blind, placebo controlled trial. patients schedule for primary pci or elective pci will randomly allocated to receive either a single dose of epo (recormon, roche, epoetin beta) or saline intravenously before pci. the investigators assume that the incidence rate of cin will be significantly lower in the epo group compared to placebo. in addition, epo administration will result in a decrease of infarct size.

radiological procedures utilizing intravascular contrast media are being widely applied for both diagnostic and therapeutic purposes. this has resulted in the increasing incidence of procedure-related contrast-induced nephropathy (cin), which was found to be associated with poor outcome including higher in-hospital mortality rates. therefore, finding ways to prevent cin is a valuable clinical and research goal. however, there are no current methods for efficient and cost-effective prevention cin. erythropoietin (epo) has been shown to elicit tissue-protective effects in various experimental models and few clinical studies of acute kidney injury (aki). therefore, this prospective, randomized, double blind, placebo controlled trial aim to evaluate, for the first time, the effectiveness of epo in the prevention of cin after percutaneous coronary intervention (pci). the potential reno-protective effect of epo is expected to reduce the incidence of the third leading cause of hospital-acquired acute kidney injury. the above together with a cardio-protective effect of epo is expected to reduce patient's morbidity, mortality and the high health cost associated with cin treatment.

Eligibility criteria:
inclusion criteria: * over 18 years of age. * diabetic patients. * egfr \< 60 ml/min/1.73m2. * scheduled for primary or elective pci. exclusion criteria: * non diabetic patients. * patients with egfr ≥ 60 ml/min/1.73m2. * chronic renal replacement therapy. * subject with active malignancy. * subject with any known history of seizure disorders. * subject with polycythemia. * uncontrolled hypertension. * known allergy or hypersensitivity to epo. * use of epo 1 week prior to randomization. * use of long acting epo (cera) during 1 month prior to randomization. * use of nac or bicarbonate during 3 days prior to randomization. * contrast media exposure during the last 7 days before randomization. * pregnant or lactating women. * participation in other clinical trial. * refusal or inability to give informed consent due to mental or physical state.

Keywords: scheduled for pci
passive leg raising - an important diagnostic manoeuvre

Conditions: Cardiovascular Insufficiency

Summary: the aim is to describe the physiological background for plr and the interpretation of a plr manoeuvre. the protocol entails the measurement of stroke volume (sv) at baseline (semirecumbent patient position), during plr and after returning to semirecumbent position. simultaneously blood pressure (bp), pulse rate (pr), pulse oximetric saturation (spo2) and ecg are recorded. the procedure is performed in ten normal subjects, ten patients recruited in the cardiology outpatient department and ten critically ill patients under analgosedation in the icu. analysis includes changes in measured variables and heart rate variability in the frequency domain during the three phases of the experiment.

see above

Eligibility criteria:
inclusion criteria: consenting after written and oral information exclusion criteria: contraindications to plr: intracranial or abdominal hypertension
comparison of topical and infusion tranexamic acid after total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: the purpose of the study, therefore, is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of txa in different tka patients groups with rivaroxaban for vte prophylaxis, first group by topical application, second group by infusion and a third group of placebo and observe whether there is difference in the occurrence of venous thromboembolism in those patient groups by venographic study

investigators previous experiences in minimally invasive (mis) tka showed that intraoperative infusion of txa reduced 45% of postoperative blood loss and needs for transfusion from 20% to 4%. however, most of the orthopedic surgeons still hesitate to use txa systemically in tkas especially in high risk patients with a potential increase in thromboembolic events following surgery. because of this concern, recently, there were few reports demonstrating the cost-effectiveness of topical application of txa in tka patients. however, most of the reports compared the topical txa with placebo in tka patients, not with intravenous txa. recently, georgiadis et al. conducted a double-blind, randomized controlled clinical trial are demonstrated similar transfusion rate and perioperative blood loss between topical administration and intravenous injection of txa in tka patients. there were no significant safety differences between the two groups. low-molecular weight heparin (lmwh) was used for thromboembolism prophylaxis in that study. recently, chemical vte prophylaxis such as rivaroxaban has been approved as a standard care after tka because of its superior convenience and efficacy on vte prophylaxis to lmwh in tkas. however, because of direct blockage of the formation of thrombin from prothrombin by rivaroxaban, an increased postoperative bleeding has been reported. there have been little studies investigating the blood-conservation effect of txa on tka patients either by infusion or by topical application when rivaroxaban used as vte prophylaxis.

Eligibility criteria:
inclusion criteria: * end-stage arthritis of the knee * failure of medical treatment or rehabilitation * hemoglobin \> 10g/dl * no use of non-steroid anti-inflammatory agent one week before operation exclusion criteria: * preoperative hemoglobin ≦10 g/dl * history of infection or intraarticular fracture of the affective knee * renal function deficiency (gfr \< 55 ml/min/1.73m2)which is relative contraindicated for venography * elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy (including long-term use anticoagulant) * history of deep vein thrombosis, ischemic heart disease or stroke

Keywords: tranexamic acid total knee arthroplasty rivaroxaban
hypophosphatemia as a predictor in surgical resuscitation sepsis

Conditions: Hypophosphatemia; Infection

Summary: retrospective study in the surgical intensive care unit of the brest teaching hospital (france) during a 6-months period (january 2015 -may 2015) to study the independent association between hypophosphatemia and 28-day infection.


Eligibility criteria:
inclusion criteria: * adults exclusion criteria: * less than 18 years old * infected at admission
minirin versus oxybutynin for nocturnal enuresis in children

Conditions: Nocturnal Enuresis

Summary: nocturnal enuresis is among the most common disorders in children. the aim of current study was to compare the efficacy and safety of minirin and oxybutynin for treatment of nocturnal enuresis in children in bandar abbas in 2014.

nocturnal enuresis is among the most common disorders in children. several pharmacological and non-pharmacological treatments are available for nocturnal enuresis. studies for reaching the best pharmacological treatment for this disorder are continuing. the aim of current study was to compare the efficacy and safety of minirin and oxybutynin for treatment of nocturnal enuresis in children in bandar abbas in 2014.

Eligibility criteria:
inclusion criteria: * \>5 years old * nocturnal enuresis * candidate for pharmacological treatment exclusion criteria: * children who their parents did noted filled the informed consent form * impossibility of follow up during the study period * history of seizure * history of rheumatologic disorders such as sjogren's disease

Keywords: minirin oxybutynin nocturnal enuresis