Kornimate/medical-research-clean huggingface dataset:
dynamics of human papilloma virus interactions; internet-based students health research enterprise

Conditions: Infection by Human Papilloma Virus

Summary: human papillomavirus (hpv) infection is the most common sexually transmitted infection. the high risk oncogenic types, hpv-16 and -18 are responsible for 70% of cervical cancers. the introduction of vaccination against two major oncogenic genotypes of hpv raises questions about genotype replacement because of the existence of other oncogenic types not targeted by the vaccine. a better understanding of natural history of hpv infection and interaction (competition, synergy) between genotypes are required in order to anticipate this phenomenon. the aims of this study are to characterize hpv infection in young female students and to follow up hpv infection and co-infection dynamics with different genotypes, taking into account both vaccination status and immunity to hpv 16 and 18. the study also focuses on the determination of factors influencing the development of persistent cervical hpv infections. the dypavir-ishare study is based on the participation of 5000 young female students, from 18 to 20 years-old, all registered at the universities of bordeaux or versailles saint-quentin (uvsq). the 3-years follow-up includes completion of a self-administrated questionnaire regarding sexual behaviour, socio-demographic characteristics, access to health-care services and, for a sub-group of 1000 students, the taking of genital and oral self-taken samples for the detection and genotyping of hpv (every 3 months). previously, a pilot phase study (2 visits in 3 months of interval) is set up on 50 young female students from uvsq in order to test feasibility. this study will provide data to gain insight into the possibility of type replacement. moreover, this study would provide an overview of hpv vaccine coverage and effectiveness hpv incidence and factors associated with hpv infection and co-infection ; partners recruitment would allow us to follow hpv transmission dynamics among couples, and in particular, hpv exposure in young adult women. the hpv research won't be limited to virus detection in samples but will indicate the presence or absence of hpv infection. finally, additional genetic studies could be conducted in order to study genetic susceptibility to hpv infection, to chronic hpv infection and to co-infection. this research project is part of the i-share program funded by the "investissement d'avenir" cohort call.


Eligibility criteria:
women inclusion criteria: * voluntary student consulting the health service of university * age 18-20 y.o. * informed consent signed * affiliated to national health insurance exclusion criteria: * pregnancy * end of the pregnancy within the last 3 months * student participating in another clinical trial men inclusion criteria: * being the sexual partner of a woman included in this study * at least 18 y.o * informed consent signed * affiliated to national health insurance exclusion criteria: none

Keywords: human papilloma virus young women i-share
switchover trial from imiglucerase to plant cell expressed recombinant human glucocerebrosidase

Conditions: Gaucher Disease

Summary: this is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with gaucher disease who are currently being treated with imiglucerase (cerezyme®) enzyme replacement therapy.

this is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with gaucher disease who are currently being treated with imiglucerase (cerezyme®) ert. eligible patients will enter a 12-week stability evaluation period to establish the stability of their disease. patients with stable disease will then be switched from their imiglucerase treatment to receive intravenous (iv) infusions of taliglucerase alfa every two weeks for a total of 20 iv infusions. the dose of taliglucerase alfa will be equal to each patient's previous imiglucerase dose. the infusions will be administered at the selected investigational site (clinic/hospital), infusion center, or at home. at the end of the 9-month treatment period (20 visits, 38 weeks) eligible patients will be offered enrollment in an open-label extension study.

Eligibility criteria:
inclusion criteria: * males and females, 2 years or older * confirmed diagnosis of gaucher disease by the enzymatic activity assay * stable gaucher disease * treatment with imiglucerase (cerezyme®) for at least 2 years and on a stable maintenance regimen (dose and regimen unchanged, except for situation of drug shortage) for at least the last six months * able to provide written informed consent exclusion criteria: * currently taking another experimental drug for any condition * history of allergy to carrots * history of allergy to beta lactam antibiotics * previous infusion reaction suspected to be allergic in nature to cerezyme® or ceredase® or receiving premedication to prevent infusion reactions * presence of hiv and/or hbsag and/or hepatitis c infection * presence of unresolved anemia due to iron, folic acid or vitamin b12 deficiency * presence of any significant comorbidity that could confound the interpretation of the clinical response to taliglucerase alfa * presence of any medical, emotional, behavioral or psychological condition that in the judgment of the investigator would interfere with the patient's compliance with the requirements of the study

Keywords: gaucher disease imiglucerase glucocerebrosidase enzyme replacement therapy lysosomal storage disorder
neurosarcoidosis : initial presentation and disease course

Conditions: Neurosarcoidosis

Summary: neurosarcoidosis represents up to 10% of sarcoidosis cases. little is known about its long-term course, even if the disease remains mainly monophasic with/w.o. sequelae, or if bouts of new symptoms may arise over years (polyphasic). using retrospective data from patients diagnosed with neurosarcoidosis in three french referral centers for neuro-inflammation, the investigators aim to determine patterns of disease course, according to the initial presentation and the treatments used.

sarcoidosis is a systemic inflammatory disease which a 10-20/100.000/year incidence rate. the nervous system is found to be affected in 5-10% in clinical series, rising to 14-27% in post-mortem studies. mortality is as high as 5% mainly due to cardiac, pulmonary or neurological injury. the treatment of the disease uses cortico-steroids, and often steroid-sparing immunosuppressive agents such as methotrexate or cyclophosphamide. more recently, tnfalpha-blockers have been found to be highly effective. long-term data about the clinical and paraclinical course of the disease are lacking. "bouts" or "relapse" of the disease are barely described, with no substantial information about their frequency, their sequelae, or their response to the treatments when initiated. less is known about the risk of recurrence in each presentation of neurosarcoidosis (peripheral, spinal, brain or meningeal presentations). in the end, if a truly relapsing-remitting form of the disease exist is not sure, many patients presenting with a lond-standing pattern of invariant symptoms. due to this lack of knowledge about the natural history of neurosarcoidosis, even a "good treatment response" cannot be defined, and in many cases, it is difficult to attribute to treatments a seemingly favourable course af the disease. in the current study, the investigators aim to build a retrospective cohort of patients diagnosed with neurosarcoidosis and seen at least once in three french referral centers for neuro--inflammation from jan-1st-2000 to date : nancy (lorraine, north-eastern), bordeaux (aquitaine, south-western) and strasbourg (alsace, north-eastern). demographics, clinical and paraclinical data at presentation will be collected(magnetic resonance imaging of the spine and brain, electroneuromyography if available, data of blood and cerebro-spinal fluid). after having clustered patients by presentation pattern, data about lines and types of treatments, change in clinical and paraclinical data will be collected. from this perspective, patterns of disease course on the mid/long-term will be established. estimated number of patients : 60-100. estimated duration of follow-up : 5-10 years. intervention : none (existing data).

Eligibility criteria:
inclusion criteria: * to have at least one documented visit in one of the three referral neurological centers (nancy, bordeaux, strasbourg) between jan-1st-2000 and jan-1st-2021 * to be diagnosed with possible/probable/definite neurosarcoidosis exclusion criteria: - denial to participate to the study
autosomal dominant polycystic kidney disease (adpkd) study

Conditions: ADPKD

Summary: autosomal dominant polycystic kidney disease (adpkd) is the most common genetic cause of renal failure. for several decades, adpkd was regarded as an adult-onset disease. in the last decade, it has become more widely appreciated that the disease course begins in childhood. however, evidence-based guidelines on how to manage and approach children diagnosed with or at-risk for of adpkd are lacking. overall, there is insufficient data on the clinical course during childhood. the study intends to get more information on autosomal dominant polycystic kidney disease (adpkd) and other hepato/renal fibrocystic diseases. additionally, the study intends to expand web-based resources so anyone can learn about adpkd or other hepato/renal fibrocystic diseases. individuals diagnosed with the dominant form of a hepato/renal fibrocystic condition are invited to be in the study.

this study will ask the subject's permission to see past, current, and future medical information related to the disease. some information that is collected, would be clinic notes, lab results, and physician consult reports. the subject will be asked to sign a release of medical information form to allow the study team access to medical information.this study does not require a clinic visit to the center. when the research study receives the information, the research study team will be able to enter the medical data into the hepato/renal fibrocystic diseases clinical database. there will be initial data entry in the database and follow up data entries lasting for the duration of this study or until the subject chooses to not participate in the study anymore. the study team will remove the subject's name or any other identifiable health information from the received records before entering medical data into the hepato/renal fibrocystic diseases clinical database.

Eligibility criteria:
inclusion criteria: * demonstration of adpkd by clinical information, imaging studies, biopsy, autopsy, or genetic testing. exclusion criteria: * patients with autosomal recessive polycystic kidney disease (arpkd), urinary tract malformations or major congenital anomalies of other systems suggesting a diagnosis other than recessive hepato-renal fibrocystic diseases.
effects of ciclesonide mdi 50mg/day and 200mg/day (ex-valve) once-daily on growth in children with mild persistent asthma

Conditions: Asthma

Summary: the primary objective is to determine if cic 50 mg/day or 200 mg/day (ex-valve) administered once daily in the morning is non-inferior to placebo with respect to growth velocity in children with mild persistent asthma following a 12-month treatment period the secondary objective is to investigate changes in growth in terms of bone age (wrist x-ray), and maintenance of asthma control and safety with ciclesonide


Eligibility criteria:
inclusion criteria: * females between 5 and 7.5 years and male between 5 and 8.5 years of age with normal heights, a history of mild persistent asthma for at least 3 months prior to visit 1, a forced expiratory volume in one second (fev1) of ³80% of predicted following at least a 4-hour albuterol withhold, and treated with non-corticosteroid asthma medications on an as-needed or daily basis, or with low doses of inhaled corticosteroids (icss) for at least one month prior to visit 1. subjects were to be no greater than stage 1 in the tanner classification of sexual maturity, and they had to be able to demonstrate effective use of the mdi devices and perform reproducible pulmonary function test. exclusion criteria: * subjects with a history of life-threatening asthma, severe respiratory impairment, history of abnormal growth, concurrent disease or condition which may substantially affect growth, previous requirement for daily or alternate day oral corticosteroids (ocs) treatment for ³60 days within the 2 years of visit 3 and/or any use of ocs within 30 days prior to visit 1 or during the run-in period, previous treatment with moderate or high doses of inhaled corticosteroid during the 30 days prior to visit 1

Keywords: asthma safety pediatrics
resync-af (rate vs rhythm control in af patients with crt-d)

Conditions: Atrial Fibrillation

Summary: this study is being done to find out if controlling rate or controlling rhythm is better for heart failure patients who also have af. patients with af who are receiving a crt-d device and av node ablation as part of their clinical care will be followed for one year. one group will have their heart rate controlled by the icd and avn ablation alone and the second group will be treated with the icd, avn ablation and standard medical therapies to restore the heart's normal rhythm. the study doctors will compare the information collected from all of the subjects in this study to see if treating rate or treating rhythm is better in patients with heart failure and af, resulting in a better quality of life.


Eligibility criteria:
inclusion criteria: * having persistent af, defined as af that does not self terminate for at least 24 consecutive hours. * in af upon entry into the operating room for crt-d implantation and av node ablation. * being on a stable dosage of an ace inhibitor or arb for at least 1 month preceding implant * being on a beta-blocker for at least 3 months preceding implant and a stable dosage within 1 month of implant * not taking or able to be taken off all type i/iii antiarrhythmic medications. * taking coumadin so as to maintain an inr of between 2 and 3. * a class i or iia icd indication * nyha class iii/iv within 1 month of baseline * intrinsic qrs duration ≥ 130 ms within 1 month prior to baseline * left ventricular ejection fraction ≤ 35% (method per physician discretion) within 1 month prior to baseline * left ventricular end diastolic dimension (lvedd) ≥ 55 mm (method per physician discretion) within 1 months prior to baseline * willing to provide written informed consent * are expected to survive for 6 month of study participation * able to tolerate an urgent thoracotomy * able to tolerate \< 1 mg dexamethasone sodium phosphate (steroid) exclusion criteria: * having self-terminating or interminable af * having unstable angina, or having experienced an acute myocardial infarction (mi) or received coronary artery revascularization (cabg) or coronary angioplasty (ptca) within the past 1 month * post-heart transplant (patients on heart transplant list for the first time are not excluded) * having mechanical right heart valve * having an existing crt or atrial therapy device(s) * being enrolled in any concurrent drug and/or device study which would confound the results of this trial * having primary valvular disease and indicated for valve repair or replacement * having a previous av node ablation * being on a type i or type iii anti-arrhythmic medication for the treatment of ventricular tachyarrhythmias * women who are pregnant or with child bearing potential and who are not on a reliable form of birth control

Keywords: heart failure crt-d
infusion laboratory: protocol 4 (dihydrexidine) - 13

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate safety issues pertaining to dihydrexidine (dhx), to cocaine, and to its interaction, and to determine how pretreatment with dhx modifies the subjective as well as physiological effects of cocaine infusion.


Eligibility criteria:
inclusion criteria: m/f, ages 21-50. meet dsm-iv criteria for cocaine dependence. agree to conditions of the study and sign informed consent. exclusion criteria: psychiatric disorder that requires medication therapy. history of seizures. pregnant and/or nuring women. dependence on etoh or benzodiazepines or other sedative/hypnotics. acute hepatitis. other medical condtions that deem participation to be unsafe.

Keywords: cocaine dependence
the role of tuberculosis in chronic obstructive lung disease

Conditions: The Role of Tuberculosis in COPD

Summary: influence of tuberculosis (tb) on natural course of chronic obstructive lung disease (copd) has not been well known. this study was designed to investigate the effects of history of tb on the long-term course of copd.

patients hospitalized with copd exacerbation were consecutively included (n=598). cases were classified into two categories: those with a history of tb and those without. clinical, demographic, and radiological features were meticulously recorded and patients were followed up for mortality. 93 patients (15%) had past tb. on average, patients with a history of tb were four-year younger (p=0.002). our study revealed that patients with tb history were diagnosed with copd five-year earlier and died five-year earlier as compared to the patients without tb. in addition, in the tb history positive group, the rate of hospital admissions per year was higher compared to the group that lacked tb history (2.46±0.26 vs. 1.56±0.88; p=0.001). the patients with tb history had higher paco2 and lower fev1 (p=0.008 and p=0.069 respectively). median survival was 24 months for patients with past tb, and was 36 months for those without. kaplan-meier analysis revealed that although 3-year survival rate was lower in patients with tb history, it was not statistically significant (p=0.08). cox regression analysis showed that while factors such as age, paco2, hematocrit, bmi and the charlson index affected mortality rates in copd patients (p\<0.05), prior history of tb did not seem to have a significant impact on the mortality. our results showed that past tb caused more hospitalizations, lower respiratory functions and higher arterial carbon dioxide levels. it was found that, though the mortality rates were similar, copd patients with past tb was diagnosed and died five-year earlier. we conclude that history of tb has an important role in natural course of copd.

Eligibility criteria:
inclusion criteria: * being diagnosed with copd exacerbations exclusion criteria: * not diagnosed with copd exacerbations

Keywords: copd, tuberculosis, mortality
abvn phase 2-studying the effect of stimulation on the auricular branch of the vagal nerve -b

Conditions: Gastro-Intestinal Disorder; Gastroparesis

Summary: the purpose of this study is to find out if manual stimulation of the vagus nerve is possible. the vagus nerve is a largely-internal nerve that controls many bodily functions, including stomach function. the hope is that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve.

the purpose of this study is to find out if it is possible to gain access to the vagus nerve which is largely an internal nerve that controls stomach function. the hope is to gain access to the internal vagus nerve by electrically stimulating the nerve around the external ear. if this is possible to do this then there is hope that this will help the treatment of patients with nausea and vomiting and disordered stomach function. healthy subjects and subjects with gastroparesis will be recruited. subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve and also undergo blood draw before, after stimulation and later a third draw after a period of no stimulation. healthy subjects will also undergo vagal maneuver using the multi array electrodes (mea). subjects will also complete health history questionnaires.

Eligibility criteria:
inclusion criteria: * volunteers with no gi symptoms * ages 18-80 * undergoing vns therapy as part of clinical treatment for focal or partial epilepsy or seizure * willing to have mea electrodes placed on the neck and bipolar electrodes placed on chest and stomach exclusion criteria: * unable to provide consent * having gastric motility issues (not due to covid 19) as determined by the pi or sub i * taking medications affecting gastric motility * pregnant females * prisoners
99mtc-qulic-5-p1 spect imaging in patients with prostate cancer

Conditions: Prostate Cancer Stage; PSMA; SPECT

Summary: 99mtc-qulic-5-p1 is a new radiotracer targeting psma, which is promising as an excellent imaging agent applicable to psma positive prostate cancer. this study will investigate the safety, biodistribution and potential usefulness of 99mtc-qulic-5-p1 spect imaging for the diagnosis of lesions in psma positive prostate cancer.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age. 2. signed informed consent. 3. patients with suspected or newly diagnosed or previously prostate cancer, with psma positive expression (supporting evidence may include mri, ct, and pathology report, etc). exclusion criteria: 1. patients with psma negative expression. 2. patients with pregnancy. 3. the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent. 4. known or expected hypersensitivity to 99mtc-qulic-5-p1 or any of its components. 5. any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
levonorgestrel-releasing intrauterine system for the treatment of symptomatic adenomyosis

Conditions: Adenomyosis

Summary: objective: to investigate the effects of levonorgestrel-releasing intrauterine system (lng-ius) for symptomatic adenomyosis. methods: from december, 2006 to december, 2014, symptomatic patients of adenomyosis diagnosed (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient clinics of peking union medical college hospital were given the treatment of lng-ius. before and after placement of lng-ius, during each following period, all the parameters were recorded prospectively, including carrying status of ius, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects. primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea second outcome measures: carrying status of ius


Eligibility criteria:
inclusion criteria: * women with regular menses * adenomyosis diagnosed via transvaginal ultrasound * with severe dysmenorrhea (vas ≥ 7) and/or menorrhea (pictorial chart scores \>100) * duration of placement \> 12 months * size of uterus by physical examination less than uterus of 12-week pregnancy exclusion criteria: * desire for pregnancy or lactation * with diagnosis of malignancies or precancerous lesions * acceptance of laparotomy * contraindication of placing levonorgestrel-releasing intrauterine system

Keywords: levonorgestrel-releasing intrauterine system adenomyosis