Kornimate/medical-research-clean huggingface dataset:
evaluation of the safety and immunogenicity of three consistency lots and a high-dose lot of rvsv-zebov-gp (v920 ebola vaccine) in healthy adults (v920-012)

Conditions: Prevention of Ebola Infection

Summary: the study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rvsv-zebov-gp (v920 ebola vaccine) in healthy adults. the primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of v920 through 28 days postvaccination. in addition to the 3 lot groups, a high-dose group and a placebo group were studied. a subset of participants representative of all treatment groups continued through 24 months postvaccination in the extension study for the evaluation of long-term safety. the primary hypothesis states that the geometric mean titer of anti-zaire ebolavirus envelope (zebov) glycoprotein antibody at 28 days postvaccination is equivalent across the three consistency lots.


Eligibility criteria:
inclusion criteria: * not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner for 2 months following study vaccination. exclusion criteria: * is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 90 days of participation in this trial. * has previously been randomized in another clinical trial and received v920 or any other ebola vaccine. * has been exposed to ebola virus at any time prior to study entry. * is pregnant or breastfeeding or plans to conceive within 2 months following study vaccination. * has direct household exposure to a pregnant or lactating woman at the time of participation in this trial. * has had a fever (≥100.5ºf/38.0ºc) within 48 hours prior to study entry. * has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing \>10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to study entry. * has received systemic corticosteroids exceeding physiologic replacement doses (\~5 mg/day prednisone equivalent) within 14 days prior to study entry. * has received any live virus vaccine within 30 days prior to study entry or any other (nonlive virus) vaccine within 14 days prior to study entry. * has known or suspected impairment of immunological function (e.g., hiv positive). * has direct household exposure to a person with known or suspected impairment of immunological function (e.g., hiv positive). * has a clinically significant history of intravenous (iv) drug abuse within 12 months prior to study entry. * has a known allergy/sensitivity or contraindication to investigational product(s) or its/their excipients (e.g., albumin). * has a history of malignancy \<=5 years prior to study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. * is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
bag valve mask vs non-rebreather at flush rate

Conditions: Respiratory Failure

Summary: healthy volunteers will participate in a crossover trial comparing preoxygenation with a non-rebreather mask to a bag-valve mask (with and without a simulated mask leak) at the flush rate of oxygen (fully opening standard oxygen flowmeter).


Eligibility criteria:
inclusion criteria: * age \>17 exclusion criteria: * pregnant * any facial hair more than stubble that might impede a mask seal
evaluation of the association of polymorphisms in the innate immune system with the risk for blastomycosis dermatitidis infection in patients not infected with hiv and complications associated with blastomycosis dermatitidis infection

Conditions: Blastomycosis

Summary: innate immunity plays an important role for fungal recognition and initiation of fungicidal activity. we hypothesize that subtle differences in different molecules of innate immunity may contribute to either the predisposition or clinical course of infection with blastomycosis dermatitidis. to test this hypothesis, we propose to analyze the allelic frequencies of 15 different genes (mannose binding lectin, fc-gamma receptor iia and iib, fc-gamma receptors iiia and iiib, myeloperoxidase, tumor necrosis factor-alpha and -beta, interleukin 1a and 1b, interleukin-1 receptor antagonist, interleukin-10, nramp-1, chitotriosidase, and chemokine receptor 5) and their intragenic polymorphic forms and to compare this data to the incidence and severity of blastomycosis dermatitidis infection. with this study we hope to identify a group of molecules of innate immunity which influence the risk and severity of invasive blastomycosis dermatitidis infection.

innate immunity plays an important role for fungal recognition and initiation of fungicidal activity. we hypothesize that subtle differences in different molecules of innate immunity may contribute to either the predisposition or clinical course of infection with blastomycosis dermatitidis. to test this hypothesis, we propose to analyze the allelic frequencies of 15 different genes (mannose binding lectin, fc-gamma receptor ila and iib, fc-gamma receptors iiia and iiib, myeloperoxidase, tumor necrosis factor-alpha and -beta, interleukin 1a and 1b, interleukin-1 receptor antagonist, interleukin-10, nramp-1, chitotriosidase, and chemokine receptor 5) and their intragenic polymorphic forms and to compare this data to the incidence and severity of blastomycosis dermatitidis infection. with this study we hope to identify a group of molecules of innate immunity which influence the risk and severity of invasive blastomycosis dermatitidis infection.

Eligibility criteria:
* inclusion criteria: patients in the database have been confirmed with a diagnosis of blastomycosis dermatitides infection by a combination of isolation of the yeast form in a diagnostic microbiology laboratory and/or an elevated cryptococcal antigen titer (which is commercially available). only patients diagnosed and treated in the united states and canada will be included in this analysis. only patients who are not co-infected with hiv will be included in the study. patient samples will be collected and clinical data will be evaluated only after signed consent has been obtained.

Keywords: genetic variant alleles risk factor cancer transplantation
misobold - prostate cancer hypoxia using bold mri and 18f-miso pet imaging

Conditions: Prostate Cancer

Summary: this feasibility exploratory study objective is to assess the ability of combined mri bold and 18f-miso pet imaging to visualize tumor hypoxia compare to histological results obtained after radical prostatectomy in order to, in time, be able to identify patient with bad prognostic and to offer them the best therapeutic strategy.

prostate cancer is the fisrt one in male with 80.000 new cases each year in france. forty thousand curative treatments are performed each year, but 25 to 30% of these patients will present a cancer reccurence after radical surgery or conformationnal radiotherapy, tissu hypoxia seems to be mainly responsible of the local reccurence and conduct to molecular damages that creates carcinogenesis and tumor agressitivity. this hypoxia inhibits the dna healing and the apoptosis but increases the angiogenesis, that leads to treatment resistance. l. marignol \&al clearly showed that hypoxia may have a main role in hormonal resistance. furthermore, m. milosevic \& al showed that hypoxia is an independent factor of local reccurence after radiotherapy. nowadays, new technics of imrt in radiotherapy planning could be able to target an hypoxic prostate region to prevent reccurence. patients who are eligible to radical prostatectomy will benefit of a prostate mri with bold sequences and a 18f-misonidazole pet before surgery. the results of these two technics will be compared to the histological results using caix and hif immunohistochemistery markers

Eligibility criteria:
inclusion criteria: * patient above 18. * prostate tumor with histological confirmed diagnosis and highly radiological suspected target on mri * high risk patient : \>t2c grade, glasgow score \> 7 and psa \> 20ng/ml * surgical treatment chosen during multidisciplinary meeting * ecog ≤2 * patient must have undergone mri with bold sequence less than 6 month prior surgery * member or beneficiary of a social security system. * signed informed consent. exclusion criteria: * patient included in another clinical study * geographical, social or psychological reasons preventing patient from submitting to the study's medical monitoring * patient deprive of liberty, adult subjects to legal protection or unable to give consent * contraindications to mri * contraindication to gadolinium injection

Keywords: prostate cancer mri bold 18f-miso pet
holter of movement in patients with sma undergoing treatment.

Conditions: Spinal Muscular Atrophy

Summary: acti-sma is a multi-centric academic study. it aims to monitor the progress of patients with spinal muscular atrophy under treatment with spinraza° or risdiplam. first, we want to quantify improvement of both ambulant and non-ambulant patients under treatment. a secondary objective would also be to identify suitable accelerometric measurements that are sensitive to change but also well correlated to other clinical scores.


Eligibility criteria:
inclusion criteria: * genetically confirmed spinal muscular atrophy. * treatment by spinraza ° or by risdiplam planned. * over 6 years old. * signed informed consent. exclusion criteria: - patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.

Keywords: actimyo accelerometry motor neuron disease risdiplam nusinersen home monitoring
development of a questionnaire to measure hypervigilance for visceral pain

Conditions: Irritable Bowel Syndrome

Summary: the aim of this study is to develop and validate a questionnaire (non-invasive technique) to identify patients who are hypervigilant for noxious visceral sensations and who show a lower threshold to report pain. this questionnaire would be useful in studies investigating the role of visceral pain hypervigilance and pain sensitivity in the comorbidity of ibs with other somatic disorders.

methods: there are two phases to the project: (1) development of the pool of items (questions), and (2) validating individual items based on their correlation with an objective gold standard - the response criterion statistic, b, calculated from a barostat test of pain sensitivity. we will perform barostat tests of pain thresholds and other measures of pain sensitivity that are based on sensory decision theory analysis in a relatively large group of 84 ibs patients. sensory decision theory divides pain perception into two components: a perceptual sensitivity index (p(a)) and a response criterion (b). the response criterion is sensitive to cognitive and psychological influences on pain perception. we will use this index (b) as the gold standard against which to select items for a scale to measure hypervigilance for visceral pain. the process will involve (a) pooling items from existing questionnaires that seem related to the concept, (b) obtaining additional questions from consultants who are experts in visceral perception and psychometric test development, (c) identifying the items that show the strongest correlations with the response criterion, (d using principal components analysis to reduce the items to the smallest number of non-redundant items that predict the response criterion and treating this as a provisional questionnaire of hypervigilance, and (e calculating psychometric characteristics of this questionnaire.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ibs * meets rome iii criteria for ibs * women or men aged 18 or older exclusion criteria: * use of ibs-specific compounds, opiates, anticholinergics, or any drug likely to cause constipation as a side-effect * use of analgesics for 48 hours prior to the study * hypothyroid * history of bowel resection except appendectomy or cholecystectomy * psychotic disorder, major depression, substance abuse (other than tobacco)or other psychiatric condition likely to interfere with the conduct of the study * renal disease * patients with inflammatory or ischemic disease of the rectum * known to be unreliable.

Keywords: questionnaire development hypervigilance pain sensitivity
single and repeated dosing study to assess the safety and the concentration-time profile of sar228810 in alzheimer's patients

Conditions: Alzheimer's Disease

Summary: primary objective: - to assess the safety and tolerability of escalating single and multiple doses of sar228810 in patients with alzheimer's disease (ad) secondary objective: - to evaluate the pharmacokinetic properties of sar228810 after escalating single and multiple doses of sar228810 in ad patients

14.5 to 22 months

Eligibility criteria:
inclusion criteria: * male or female patients with mild to moderate alzheimer's disease, aged between 50 and 85 years inclusive * meets criteria for probable alzheimer's of the national institute of neurologic and communicative disorders and stroke - alzheimer's disease and related disorders association * mini-mental state examination (mmse) * in reasonable and stable health state for alzheimer's patients of this age and stage of disease as assessed by a comprehensive clinical assessment * magnetic resonance imaging consistent with alzheimer's disease, not indicating any other cause for dementia symptoms than alzheimer's disease * rosen modified hachinski ischemic score * if on symptomatic treatment for alzheimer's disease (acetylcholinesterase inhibitors or/and memantine), must be stable in the last 30 days before screening exclusion criteria: * clinically significant neurological disease other than alzheimer's disease * had a major psychiatric disorder * had a history of stroke, seizures, brain neoplasms, brain surgery, or any cerebrovascular disorder (including transient ischemic attack) * history or presence of severe, uncontrolled and/or unstable angiopathy or vasculitis. * history or presence of clinically relevant cardiac disease. * currently taking anticonvulsants, anti-parkinsonians, antipsychotics, anticoagulants or narcotic drugs, recent immunosuppressive or cancer chemotherapy drugs, or cognitive enhancers. concomitant therapies that are allowed if given at a stable dose for at least 30 days before screening are: acetylcholinesterase inhibitors and/or memantine; antidepressants of the class of selective serotonin reuptake inhibitors (no tricyclics); acetyl salicylic acid (asa) at a dose ≤ 160 mg/day; the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: mild to moderate alzheimer's disease
the incidence of postpartum hepatitis in pregnant women with chronic hepatitis b virus infection

Conditions: Chronic Hepatitis B

Summary: the majority of childbearing age women with hepatitis b virus infection were still in the immune tolerance period. our recent research had shown that most puerperae after delivery had elevated alt level. however, there is no withdrawal time recommendations after childbirth at present.through the study of hepatitis occurrence after delivery and drug withdrawal, the investigators explore the withdrawal time of antiviral treatment during pregnancy.

most of childbearing age women with hepatitis b virus infection were still in the immune tolerance period. our recent research had shown that most puerperae after delivery had elevated alt level, and 11.5% of patients with hbv dna positive would lead to deterioration of liver function. meanwhile, the highest peak of alt level could occur in 2 weeks after delivery, then it would dropped to a low point in 4-5 weeks. however, there is no withdrawal time recommendations after childbirth at present.the aim of our study is to investigate the changes of serological indexes, the changing rule of the liver function, hepatitis status, and its correlation with antiviral therapy in pregnant women with hbv infection after delivery, and then explore the withdrawal time of antiviral treatment during pregnancy.

Eligibility criteria:
inclusion criteria: * pregnant women who were chronic hepatitis b and had achieved hbeag positive and hbv dna \> 106 copies/ml * healthy pregnant women with hbsag(-), hbeag(-) exclusion criteria: * active consumption of alcohol and/or drugs * co-infection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus, hiv, etc. * history of autoimmune hepatitis * psychiatric disease * evidence of neoplastic diseases of the liver * without gestational hypertension, premature rupture of membranes, antepartum haemorrhage diseases or amniotic fluid piercing history during pregnancy.

Keywords: antiviral treatment hepatitis b virus pregnant woman postpartum hepatitis
serratus anterior block and erector spinae block in postoperative analgesia

Conditions: Postoperative Analgesia

Summary: 90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block and erector spinae block and control group. during anaesthesia:total intraoperative fentanyl required will be recorded. after surgery, all patients will be connected to pca device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.

90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block (sab) and erector spinae block (esb) and control group. during anaesthesia: total intraoperative fentanyl required will be recorded. after surgery, all patients will be connected to pca device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. other secondary outcomes are: numerical rating scales and postoperative pulmonary functions.

Eligibility criteria:
inclusion criteria: * patients with class ii physical status (american society of anaesthesiologists) , * age between 18-70 years, * scheduled for thoracic cancer surgery exclusion criteria: * patient refusal. * local infection at the site of the block. * cardiac dysfunction (ejection fraction \<45%). * significant respiratory disorders. * preexisting neurological or psychiatric disease. * allergy to one of the study drugs. * pregnancy. * coagulopathy

Keywords: serratus anterior block erector spinae block postoperative analgesia
a trial with tmc278-tidp6-c222 for continued tmc278 access in patients infected with human immunodeficiency virus-1

Conditions: HIV-1 Infection

Summary: the purpose of the study is to provide continued access to tmc278 in hiv-1 infected patients who were randomized and treated with tmc278 in the phase iib or phase iii trials.

this is a phase iii, open-label (all people know the identity of the drug), multicenter, roll-over trial to provide continued access to tmc278 to hiv-1 infected patients who were randomized (the study drug is assigned by chance) and treated with tmc278 in the phase iib (tmc278-c204 \[c204\]) or phase iii trials (i.e., tmc278-tidp6-c209 \[c209\] or tmc278-tidp6-c215 \[c215\]) and who continue to benefit from their antiretroviral treatment, according to the investigator. in addition, information on the long-term safety and tolerability, including resistance data in case of virologic failures, of oral doses of tmc278 25 mg once daily (q.d.) in combination with a background regimen containing 2 n(t)rtis will be collected. available efficacy data will also be collected. approximately 750 hiv-1 infected individuals are expected to participate in this trial. the duration of participation in the study for an individual participant will be 2 to 3 years. the final/withdrawal visit of the phase iib or phase iii trials will be the first visit of this trial. safety and tolerability will be evaluated throughout the trial. visits and assessments performed should be based on the local, generally accepted standard of care, with visits occurring at least every 6 months. oral tablets of tmc278 25 mg once daily (q.d.) should be administered together with a meal.

Eligibility criteria:
inclusion criteria: * patients are hiv-1 infected and were previously randomized to receive tmc278 in a tmc278 clinical trial and completed the protocol-defined treatment period. * patients continue to benefit from treatment with tmc278 in the opinion of the investigator. * patient can comply with the current protocol requirements. * the patient's general medical condition, in the investigator's opinion, does not interfere with participation in the trial. exclusion criteria: * use of disallowed concomitant therapy. * females of childbearing potential who are pregnant, or without the use of effective birth control methods, or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or last intake of tmc278). * non-vasectomized heterosexually active male patients without the use of effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or after last intake of tmc278).

Keywords: hiv-1 infection hiv-1 hiv tmc278-tidp6-c222 tmc278-c222 tmc278 rilpivirine
a real world study based on ngs (trumprws)

Conditions: Non-Small Cell Carcinoma of Lung, TNM Stage 4

Summary: this is a descriptive observational study, in which data are collected in an epidemiological fashion. this study does not intend to alter or intervene the current medical practice of the recruited patients. data will be collected in prospective manner.

this is a descriptive observational study, in which data are collected in an epidemiological fashion. this study does not intend to alter or intervene the current medical practice of the recruited patients. data will be collected in prospective manner. the eligible patients will be recruited after ngs analysis for tumor tissue and the inform-consent is obtained. the study required information will be collected (every 3 months).

Eligibility criteria:
inclusion criteria: 1. patients must be ≥20 years of age. 2. provision of fully informed consent prior to any study specific procedures. 3. histologically or cytologically confirmed, unresectable stage iiib or stage iv nsclc. 4. genetic variants of tumor tissue detected by ngs. exclusion criteria: none.