Kornimate/medical-research-clean huggingface dataset:
e6/e7 mrna performance to detect hsil and cost-effectiveness analysis of this screening strategy in hiv + msm

Conditions: HPV - Anogenital Human Papilloma Virus Infection; HSIL, High Grade Squamous Intraepithelial Lesions; Anal Cancer; Hiv

Summary: this study evaluates the positive and negative predictive value of e6/e7 mrna expression for anal hsil and its capacity to predict incident hsil in hiv + msm. we also analyse the cost-effectiveness of this new screening strategy. it is an ambispective study with 355 participants and a follow-up period of 2 to 5 years.

introduction: anal cancer incidence is increasing in hiv-infected men who have sex with men (msm). there are still no standardized criteria for anal cancer screening. anal cytology has not shown enough sensitivity and specificity in the selection of patients who need more invasive procedures, as high resolution anoscopy (hra). human papillomavirus (hpv) e6 and e7 oncogenes deregulation is a crucial factor in neoplasic lesions progression. objectives: 1)to assess the negative and positive predictive value of e6/e7 mrna expression for high-grade squamous intraepithelial lesions (hsil) and its capacity to predict the incidence of new hsil during the follow-up 2)to analyze the cost-effectiveness of e6/e7 as a new screening strategy for anal cancer compared with usual strategies (cytology and dna detection). methodology: ambispective longitudinal study. participants: hiv msm from the outpatients hiv and std unit of bellvitge hospital. we include patients visited within the usual outpatient practice since january 2015 with a cytology stored following the hospital protocol, as well as patients collected prospectively since january 2017. this methodological approach will let to reduce the time of inclusion and maximize follow-up time. sample size calculated: 355 participants. follow-up period: 2 to 5 years. at each visit an anal smear for cytology, hpv dna detection (by linear array and hybrid capture) and e6/e7 mrna expression and a hra with biopsy of suspicious areas of dysplasia will be performed. the analysis of cost-effectiveness will be made with a markov model that projects long-term cost and effectiveness for both strategies, the e6/e7 and conventional cytology plus detection of high risk hpv.

Eligibility criteria:
inclusion criteria: * men who have sex with men \>= 18 years * hiv documented infection * signature of the informed consent exclusion criteria: * previous diagnosis of anal cancer. * treatment of anal intraepithelial lesions the 5 years before study inclusion. * suspect infiltrating anal cancer, requiring exploration under anesthesia and surgical removal for histological confirmation. * history of diffuse ano-genital condylomatous disease the 5 years before study inclusion or presence at first visit. * other factors that could prevent correct diagnosis and monitoring of the anal dysplastic lesions (test intolerance, proctological pathology that does not allow hra, etc.).

Keywords: e6/e7 mrna anal cancer screening men who have sex with men cost-effectiveness analysis high resolution anoscopy
perception of information and quality of life in neuroendocrine tumour on lanreotide autogel

Conditions: Neuroendocrine Tumors

Summary: the purpose of the study is to evaluate, in standard practice, the change in information received and perceived by the patient, extension of the disease and its treatment. these parameters will be evaluated by means of validated self-administered questionnaires that can be used in standard practice.


Eligibility criteria:
inclusion criteria: * gastroenteropancreatic neuroendocrine tumor (gepnet), histologically proven, grade 1 or 2, * subject eligible for antitumor treatment initiation with lanreotide autogel\*, alone or combined with other therapies, selected freely and prior to inclusion in the study by the physician, * subject able to complete a self-administered evaluation questionnaire during initiation visit and liable to be seen again within 6 months of the initial visit based on the physician's usual practices * having consented in writing to his/her data being accessed for participation in the study. exclusion criteria: * previously treated by lanreotide autogel * simultaneously participating in a clinical trial
collecting respiratory sound samples from corona patients to extend the diagnostic capability of voqx electronic stethoscope to diagnose covid-19 patients

Conditions: COVID-19

Summary: technological developments in the recent decades has enabled the integration of electronic and digital components in the stethoscope design, in an attempt to improve auditory performance and, moreover, to assist in improving user's diagnostic accuracy by incorporating computerized, digital technologies, artificial intelligence capabilities and deep-learning-based algorithms enhancing these devices. we believe that these technologies can be used to significantly improve the diagnostic performance in the primary care phase, by means of a sophisticated stethoscope that enables auscultation to sounds and signals typically found in the sub-sound frequency level. their transformation into the sound range, and the use of artificial intelligence and machine learning techniques to characterize sound patterns that correspond to specific problems or diseases can substantially enhance the physician's or other care giver's performance to the benefit of the patients. at this stage, the software in development does not purport to make diagnostic decisions, but only to provide information that will enhance decision and diagnosis making process, therefore enable a more accurate and definitive diagnostic decision and perhaps decrease the number of additional diagnostic tests requested.

up to 200 patients will participate in an open, prospective and multi-center study. patients diagnosed as positive to covid-19 will be referred to a voqx examination. all patients will receive detailed explanation about the purpose of the examination, its impact and will provide their consent prior to the examination. the voqx device output will have no influence on the decision-making process of the physicians and care givers. the voqx stethoscope membrane will be put on the patient's chest area in predefined anterior and posterior points. the data collected in the form of breath sound signals in particular infra-sound will be transferred to an external computer and processed by machine learning algorithm developed by the company. the algorithm will seek patterns typical for the diagnosed disease for each corresponding case diagnosed.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 years * rt-pcr positive for covid 19 * patients diagnosed with the following pulmonary pathology: * pneumonia * pulmonary edema * bronchitis * acute asthmatic attack * emphysema * or normal (e.g. asymptomatic patients) * the diagnosis is confirmed if possible, by: * anamnesis * physical examination * x-ray * suggestive blood test - cbc * pulse oximetry exclusion criteria: * pregnant women * chest malformation * unconsciousness * subject that need a guardian * weigh above 150 kg. * patients with current shortness of breath * patients currently assisted by breathing machine such as cpap or other

Keywords: covid-19 diagnostic viral infection disease electronic stethoscope
prevalence of spasticity in adults with mental retardation living in the community

Conditions: Mental Retardation; Spasticity

Summary: this survey aims to investigate the prevalence of spasticity among adults who live in community settings in davidson county, tennessee. the treatment of spasticity in those who live in community homes could significantly increase a person's quality of life by allowing them to participate more independently in activities of daily living, or by making assistance easier for caregivers.

the process of deinstitutionalization has transitioned a large majority of persons with developmental disabilities into the community over the past several decades, and that number will only increase going forward. there are 926 people in this region who are provided assistance through the division of mental retardation services (dmrs). people with developmental disabilities frequently have comorbidities such as spasticity that hinder their ability to participate in activities of daily living. spasticity results from brain or spinal cord injury and can produce increased muscle tone, causing joint stiffness, contractures and pain that can interfere with recommended treatment. a previous survey conducted at clover bottom developmental center investigated care areas typically affected by spasticity, including splinting, hygiene, dressing, transfers, positioning, ambulation, and engaging in other functional activities. pfister et al. reported the prevalence of spasticity in the developmental center to be 35% (72/205); of those people, the survey physician felt that 75% (54/72) would achieve a functional benefit from treatment. primary endpoints will assess the prevalence of spasticity in adults who reside in the community, and whether or not spasticity impacts activities of daily living. when appropriate, potential care area goals will be identified, and treatment options will be recorded. secondary endpoints will examine whether or not participants currently receive treatment for spasticity; if so, what treatment is being used; and which care areas are most impacted by spasticity.

Eligibility criteria:
inclusion criteria: * adult (18 and over) with mental retardation * living in a community home in davidson county, tennessee. exclusion criteria: none.

Keywords: spasticity mental retardation
placebo-controlled study of npb-06 in patients with portal vein thrombosis

Conditions: Portal Vein Thrombosis

Summary: patients with portal vein thrombosis, who have chronic liver diseases especially liver cirrhosis associated with low levels of at iii, will receive intravenous injection of npb-06 or placebo. the superiority of npb-06 to placebo as anticoagulative agent will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis. the safety of npb-06 will be evaluated based on adverse events and adverse drug reactions (adrs) observed between administration and 21 days after administration in comparison with the placebo group.


Eligibility criteria:
inclusion criteria: inpatients or outpatients meet the criteria (1)-(4) below will be enrolled in the study. patients have to provide written informed consent for voluntary participation in the study. 1. patients who the serum level of at-iii is 70% or less 2. patients with portal vein thrombosis detected by ultrasonography 3. patients who have more than 50% of the thrombus lumen occupancy 4. patients who are older than 20 years at the time of consent exclusion criteria: patients who meet any of the following criteria will be excluded from the study beforehand. 1. patients with tumor embolus in portal vein 2. patients with an ongoing hepatic intra-arterial chemotherapy such as implantable reservoir system 3. patients with hepatocellular cancer of more than 3 cm in diameter or more than four hepatocellular cancers 4. patients with residual or chronic portal vein thrombosis 5. patients with advanced liver disease (child-pugh score 11 or more) 6. patients with bleeding tendency 7. patients who had an anticoagulation therapy (intravenous or subcutaneous dose) or hemostasis with an enzymatic hemostatic agent in the period between 7 days before contrast enhanced ct of pre-dose and the day acquired written informed consent 8. patients who had an anticoagulation therapy (oral dose) in the period between 7 days before contrast enhanced ct of pre-dose and the day acquired written informed consent 9. patients with a history of shock or hypersensitivity to npb-06 10. patients with inappropriate to contrast agents * a history of allergy of iodine or x-ray contrast agent * complication of serious thyroid disease * reduced renal function 11. pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study 12. patients who have received npb-06 13. patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies 14. patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
prevention of venous thrombosis after permanent transvenous leads implantation

Conditions: Cardiac Pacing; Complications; Venous Thrombosis

Summary: the aim of this study was to compare the safety and efficacy of warfarin versus placebo, administered for 6 months, in the prevention of thromboembolic complications after transvenous cardiac devices implantation in high-risk patients.

venous lesions following cardiac devices implantation are a common complication of transvenous access that may cause disease manifestations and difficulties during reoperations. these lesions tend to develop early, and their incidence decreases gradually within 6 months after device implantation. ventricular dysfunction and previous transvenous temporary leads ipsilateral to the permanent implant are risk factors identified in a previous study performed at our institution and other risk factors have been reported recently.the usefulness of prophylactic therapeutic strategies to prevent these complications, however,remains unknown. this randomized trial examined the effects of warfarin in the prevention of these complications in high-risk patients. after device implantation, patients were randomly assigned to receive either placebo or warfarin. periodical clinical and laboratorial evaluations were performed to anticoagulant management. following the six-month period, every patient was submitted to a digital subtraction venography.

Eligibility criteria:
inclusion criteria: * adults patients submitted to first transvenous implant of pacemakers, implantable cardioverter-defibrillator, or cardiac resynchronization therapy devices * left ventricular ejection fraction ≤0.40 and/or * previous transvenous temporary leads ipsilateral to the permanent device implant exclusion criteria: * history of venous thromboembolism * atrial fibrillation * coagulopathy or platelet disorder * malignancy * gastro-intestinal hemorrhage or active gastro-duodenal ulcer in the past 6 months * abnormal prothrombin time (pt)or an international normalized ratio (inr) \>40%, or treated with oral anticoagulants

Keywords: cardiac pacing pacing complication venous thrombosis warfarin anticoagulation randomized trial
effects of physical activity on the microcirculation in hemodialysis patients

Conditions: Hemodialysis Patients

Summary: chronic kidney disease (ckd) is associated with high level of peripheral arterial disease (pad). this could lead wounds, infections then amputations or deaths by impairment of the peripheral cutaneous perfusion. medical therapies are presently unable to cure, but only slow down these disorders. impact of exercise and lower extremity pad rehabilitation is decreased by the significant inactivity of the chronic hemodialysis patients. recently, many studies have shown several various favorable effects of the perdialytic physical activity. there is currently no data about effects of the perdialytic activity on the lower extremity perfusion. the aim of this clinical study is to show the impact of three months perdialytic cycling on the microcirculation, in chronic hemodialysis patients. primary outcome will be the increase of cutaneous perfusion, assessed by measuring transcutaneous oxygen pressure (tcpo2) on about twenty patients.


Eligibility criteria:
inclusion criteria: * patients performing chronic hemodialysis for more than 3 months * adult aged \> or = 18 years old * information letter delivered to subjects * written free informed consent * clinically stable patients * voluntary patients to perform 30 minutes cycling per dialysis session * social french security affiliated subjects exclusion criteria: * subjects without inclusion criteria * pregnant women * subjects protected by the law * physical impossibility to achieve exercise * medical contraindication to perform physical exercise

Keywords: hemodialysis microcirculation physical perdialytic activity cycling
bispectral index as an analgesia monitoring in severely ill patient: effect of remifentanyl

Conditions: Pain

Summary: the aim of this protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli.

pain is difficult to estimate in icu because most of the patients are sedated. bispectral index could be helpful in detecting this pain in icu patients. remifentanil is a morphinomimetic product with short half life that could be interesting for short nociceptive stimuli, as bronchoalveolar lavage. the purpose of this study is to evaluate the impact of remifentanil infusion on bispectral index (bis) variations during bronchoalveolar lavage. it is a prospective, double blind study, versus placebo on 40 sedated and critically ill patients. the hypothesis is that bis can study analgesia in sedated patient.

Eligibility criteria:
inclusion criteria: * sedated patient with mechanical ventilation with suspected nosocomial pneumonia exclusion criteria: * pace maker * neurologic illness * hemodynamic instability * hypothermia

Keywords: bispectral index sedation remifentanyl bronchoalveolar lavage intensive care nociceptive stimuli sedated patient bis variation
evaluation of the role of plasma procalcitonin in prediction of intra-amniotic infection in preterm premature rupture of membrane

Conditions: Intra-amniotic Subclinical Infection.

Summary: it is hypothesized that the procalcitonin has a role to play in prediction of intra-amniotic subclinical infection.

study population * this study will be conducted at the department of obstetrics and gynecology recruiting pregnant women selected from the attendees of antenatal clinic, emergency department and from inpatient wards of ain shams university maternity hospital from mars2014. * this study will include 100 pregnant women these cases will be divided into 2 groups: * group 1: healthy preterm group: will include 50 pregnant females all at 24-34 weeks of gestational age . * group 2: preterm premature rupture of membrane group: will include 50 pregnant females all at 24-34 weeks of gestational age

Eligibility criteria:
patients are with singleton pregnancies. rupture of membranes will be diagnosed by history, sterile speculum examination to confirm fluid leakage from the cervical canal and ultrasound to confirm oligohydraminos. subclinical infection will be detected with laboratory indices (wbc count of ≥15, 000 c/mm3, crp of ≥1 mg/dl) without any clinical symptoms and signs of infection as urinary tract infection in group 1 patients. women with multiple pregnancies. clinical signs of infection as (fever,abdominal tendernes). cervical dilatations of 2 cm or more. maternal disease like diabetes or fetal complications like intra-uterine fetal death. inclusion criteria: - exclusion criteria: -

Keywords: procalcitonin intra-amniotic subclinical infection.
an evaluation of concordance of smartwatch ecg and one clinical ecg and comparison of the two ecgs in terms of predictive risks

Conditions: Childhood Cancer; Cardiomyopathy, Primary

Summary: the participant is being asked to take part in this trial, because the participant is a survivor of childhood cancer. primary objective to evaluate remote cardiomyopathy prediction via smartwatch and one clinical ecg and assess the concordance of the two ecgs in terms of predicted risk. secondary objective to build a novel predictive model solely on smartwatch ecg to predict risk for cardiomyopathy.

the proposed study is looking to compare the 30 second ecg read from a smartwatch to the clinical ecg during a sjlife scheduled ecg appointment.

Eligibility criteria:
inclusion criteria: * sjlife participant and 22 years of age or older at time of enrollment * participant or legal guardian is able and willing to give informed consent * at least 5 years after childhood cancer diagnosis exclusion criteria: * been diagnosed with cardiomyopathy on previous sjlife ecg * currently on heart medication
study on cefotaxime and sulbactam sodium for injection (2:1) for treatment of respiratory and urinary tract infection

Conditions: Respiratory Tract Infections; Urinary Tract Infections

Summary: in the proposed study, the investigators plan to evaluate the efficacy and safety of cefotaxime sodium and sulbactam sodium for injection (2:1)for the treatment of respiratory and urinary tract acute bacterial infection under the widely used in clinical conditions.

cefotaxime is a third-generation cephalosporins.cefotaxime sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis by irreversible competitive inhibition of β-lactamase.the antimicrobial effect of cefotaxime can be enhanced by the two combined.the compound specifically aims to the mechanism of bacterial resistance, extending the life of cefotaxime in the treatment-resistant pathogen infections.

Eligibility criteria:
inclusion criteria: 1. patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy. 2. age\>18 years old, gender: both 3. women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial; 4. patients were volunteers and signed informed consent form; 5. patients did not participate in other clinical trials. exclusion criteria: 1. patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor 2. pregnant and lactating women 3. patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness. 4. patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.

Keywords: cefotaxime sulbactam sodium phase iv clinical studies respiratory and urinary tract infections
phase 3 study of khk7580

Conditions: Secondary Hyperparathyroidism

Summary: the purpose of this study is to evaluate the efficacy and safety of khk7580 orally administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (shpt) receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment, parallel-group design with cinacalcet hydrochloride as an active control.


Eligibility criteria:
inclusion criteria: * personally submitted written voluntary informed consent to participate in the study * stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening * mean intact pth level of \> 240 pg/ml at screening, at 2 weeks and 1 week before the start of study treatment exclusion criteria: * treatment with cinacalcet hydrochloride within 2 weeks before screening; * change in dose or dosing regimen of an activated vitamin d drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening; * parathyroidectomy and/or parathyroid intervention within 24 weeks before screening; * severe heart disease; * severe hepatic dysfunction; * uncontrolled hypertension and/or diabetes; * treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening; * primary hyperparathyroidism; * other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.