Kornimate/medical-research-clean huggingface dataset:
comparison of inflammatory markers and incidence of comorbidities in patients on antiretroviral therapy with second-generation anti-integrase drugs on triple versus dual therapy

Conditions: Hiv

Summary: hiv-infected patients develop comorbidities earlier than the general population. immune activation with the secretion of pro-inflammatory cytokines would play a major role in the occurrence of these comorbidities. numerous factors, called risk factors, already identified in the general population and confirmed in patients with hiv virus favor the occurrence of these comorbidities but cannot alone explain the overrepresentation and precocity of these comorbidities in the hiv population. investigators hypothesize that optimization or simplification with certain classes of antiretrovirals modify the inflammatory response and are predictive factors for the occurrence of comorbidities


Eligibility criteria:
inclusion criteria: * hiv-1 infection * age \> 40 years or adults with more than 10 years of antiretroviral therapy * switching to bic/ftc/taf or dtg/3tc or dtg+3tc within the last 2 years * plasma hiv-1 rna viral load \< 50 copies/ml for more than 6 months * absence of chronic hepatitis b infection * absence of genotype mutations on dolutegravir (dtg) or bictegravir (bic) or tenofovir alafenamide taf * daily use of antiretroviral therapy * effective contraception for women of childbearing potential will be requested * signed informed consent * enrollment in a social security plan exclusion criteria: * non-daily or intermittent antiretroviral therapy regimen (e.g., 4 or 5 days a week) * pregnancy or breastfeeding * vulnerable persons according to article l.1121-6 of the public health code persons unable to give consent according to article l.1121-8 of the public health code * opportunistic infections during curative treatment * hiv-2 infection * active hepatitis c * refusal to participate * withdrawal of informed consent by the patient
truetear in sjogren's disease patients

Conditions: Dry Eye Syndromes; Sjogren's Syndrome

Summary: the purpose of this study is to evaluate acute tear production produced by the intranasal tear neurostimulator in participants with sjögrens syndrome and aqueous tear deficiency. our primary goal is to evaluate whether sjögrens patients respond to this intervention and whether there is a baseline tear production level below which these patients do not respond.


Eligibility criteria:
inclusion criteria: * subjects with sjögren's syndrome based on american-european consensus group (aecg) american college of rheumatology (acr), or american college of rheumatology/european league against rheumatism (acr/eular) criteria * baseline schirmer score (with topical anesthesia) of ≤10 mm/5 min and retest value (during nasal stimulation with cotton swab) of at least 4 mm/5min higher than baseline value * baseline ocular surface disease index® (osdi) total score ≥13 * age greater than or equal to 22 years old * able to complete questionnaires independently * willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol exclusion criteria: * use of any topical ophthalmic medication, including artificial tears, within 4 hours of either visit * chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding * use of systemic anticoagulants * nasal or sinus surgery including nasal cautery or significant trauma * severely deviated septum * cardiac demand pacemaker, implanted defibrillator or other implanted electronic device * have an active implanted metallic or active implanted electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator * known hypersensitivity to any of the procedural agents or materials in the study device that contact the nasal mucosa * corneal transplant in either or both eyes * participation in any clinical trial within 30 days of the screening visit * a woman who is pregnant, planning a pregnancy, or nursing at the screening visit
wes of nf2-associated in comparison to sporadic vestibular schwannomas - correlation with clinical data

Conditions: Neurofibromatosis Type 2; Vestibular Schwannoma; Acoustic Neuroma

Summary: whole exome sequencing (wes) of 50 sporadic and 50 neurofibromatosis type2 (nf2)-associated vestibularis schwannomas (vs) in children and young adults. the aim is to gain insight into the complete genome of the nf2 associated vs compared to sporadic vs (control group). these data are to be correlated with the clinic, ie the auditory function (audiogram, acoustically evoked potentials) and the clinical picture as well as the tumor growth rate and general data such as sex, age, side, etc.

whole exome sequencing (wes) of 50 sporadic and 50 neurofibromatosis type2 (nf2)-associated vestibularis schwannomas (vs) in children and young adults. the aim is to gain insight into the complete genome of the nf2 associated vs compared to sporadic vs (control group). these data are to be correlated with the clinic, ie the auditory function (audiogram, acoustically evoked potentials) and the clinical picture as well as the tumor growth rate and general data such as sex, age, side, etc. the analysis of genetic changes should provide a better insight into the oncogenesis of these tumors. the distinct genetic characteristics between nf2-associated and sporadic vs suggest a different oncogenesis of these tumors. the correlation of the genetic characteristics with the partly very different clinical appearance and a very different dynamics of the disease, in particular the tumor volume in the course, identifies the underlying modifiers of the disease course. based on these genetic modifiers, patients can be stratified and individual clinical therapy decisions can be made. by demonstrating these genetic profiles in the peripheral blood, prospective conclusions can be drawn about expected disease progression before intervention as well as for therapy monitoring

Eligibility criteria:
inclusion criteria: * study population: operated nf2-associated vs * control group: operated sporadic vs * consent to participation in the study by the patient / legal guardian in prospective inclusion or consent to the use of stored specimens in retrospective inclusion * age: 0 -99 years exclusion criteria: * lack of informed consent * patient's request (withdrawal of the consent statement for the evaluation of the data and further storage of the blood / tissue samples)

Keywords: whole exome sequencing neurofibromatosis type 2 acoustic neuroma vestibular schwannoma
online family support and education for schizophrenia

Conditions: Schizophrenia

Summary: this study evaluated the benefits of providing relatives of patients diagnosed with schizophrenia the opportunity to interact with each other using the internet. it was hypothesized that patients whose relatives had access to the internet intervention would have reduced symptoms and greater community tenure, compared to their counterparts who did not have relative access to the internet education and support program. we also collected information on how frequently the relatives used the website and how well they liked its features.

although psychoeducational programs for schizophrenia can reduce patient relapse rates and reduce family distress, participation rates are often low. this study evaluated an online model to provide the families of schizophrenia patients with knowledge of illness management to reduce family burden and increase perceived social support. relatives of patients with schizophrenia who received 12 months of customary care with access to the educational website for the first year were compared to matched group of relatives of individuals diagnosed with schizophrenia who were receiving customary care and who consented to participate in a family education program. in the education condition, relatives were provided with private, secure access to the website, which features family-to-family chat capabilities, video lectures on the management of schizophrenia, written materials on important issues in schizophrenia management, professionally facilitated online discussions of the material, and additional resource links. relatives were assessed using 90-minute interviews at the beginning of the project and every 6 months for 12 months. the interviews were used to assess the family member's perception of the patient's symptoms, his or her knowledge of the illness, the illness's impact on the family member, and his or her perception of the website intervention. patients with schizophrenia or schizoaffective disorder were also asked to complete interviews and assessments at the beginning of the project and every 6 months for 12 months. the assessments include questions about symptoms, medication compliance and side effects, hospitalizations, and social functioning. the major hypotheses were that relative participation in the online program would be associated with lower symptoms rates and hospitalizations in the patients.

Eligibility criteria:
inclusion criteria for patients: * diagnostic and statistical manual (dsm-iv) research diagnosis of schizophrenia or schizoaffective disorder * stable antipsychotic medication regimen for at least 1 month * willing to participate in in-person assessments inclusion criteria for relatives: * at least 4 hours of weekly contact with patient * willing to participate in in-person assessments * -interested in a family education program for schizophrenia

Keywords: schizophrenia family psychoeducation internet
effect of geometric modifications of implant scan bodies

Conditions: Prosthesis Durability

Summary: the aim of this clinical study will be the effect of geometric modifications of implant scan bodies compared to conventional transfer techniques on passivity of all on four mandibular restorations

the aim of this study will be the effect of geometric modifications of implant scan bodies compared to conventional transfer techniques on passivity of all on four mandibular restorations. evaluation method: the trueness of the final impression and the passivity of the final prosthesis will be evaluated by two methods: invitro evaluation for each patient in every group, the standard tessellation language (stl) files of scanned impressions will be superimposed on the reference file to determine the 3d surface, linear, and angular position analysis. the stl files for both frameworks will be superimposed on the reference file to determine the passivity. in vivo (clinical) evaluation radiographic evaluation using long cone parallel technique will be done for the framework after 6 month (t6) after one year (t12), and after 18 month (t18) from insertion.

Eligibility criteria:
inclusion criteria: * 1. all selected patients will have four implants placed in the mandibular interforaminal region according to all -on -four concept. 2. all selected patients have a healthy mucosa and with no clinical complications. 3. all patients are cooperative and approve the proposed treatment protocol. exclusion criteria: * 1. patients who reject to participate in the study. 2. patients who need implant placement as a result of previous implant failure.
efficiency, safety and portability of neovasculgen

Conditions: Peripheral Arterial Disease

Summary: in 2010, we completed a phase 1 to 2a clinical trial of pcmv-vegf165 in patients with chronic lower limb ischemia (stage 2a to 3 according to fontaine classification modified by a. v. pokrovsky) who were not suitable for reconstructive surgery or endovascular treatment. this study demonstrated the safety, feasibility, and short-term(3 months) efficacy of pcmv-vegf165 gene transfer,12,13which lead to conducting a phase 2b to 3 multicenter clinical trial. the study was conducted under the control of the russian ministry of health and was completed in 2011. patients enrolled in the study were subjected to a 6-month

we conducted a phase 2b/3 multicenter randomized controlled clinical trial of the intramuscular transfer of a plasmid dna encoding vascular endothelial growth factor (vegf) 165 with cytomegalovirus promotor (cmv) in patients with atherosclerotic lower limb ischemia. a total of 100 patients were enrolled in the study, that is, 75 patients were randomized into the test group and received 2 intramuscular injections of 1.2 mg of pcmv- vegf165, 14 days apart together with standard pharmacological treatment. in all, 25 patients were randomized into the control group and received standard treatment only. the following end points were evaluated within the first 6 months of the study and during a 1.5-year additional follow-up period: pain-free walking distance (pwd), ankle-brachial index (abi), and blood flow velocity (bfv).

Eligibility criteria:
inclusion criteria: * age more than 40 years; * a history of stable claudication for at least 3 months; * stage 2 to 3 chronic ischemia according to fontaine classification (modified by a. v. pokrovsky); * presence of hemodynamically significant (stenosis \>70% and/or occlusion) diffuse lesions of the interior and (or) posterior tibial arteries (distal lesion); * voluntary informed consent signed and dated by the patient. exclusion criteria: * chronic lower limb ischemia of nonatherosclerotic genesis; stage 4 chronic ischemia according to fontaine classification modified by a. v. pokrovsky (ischemic ulcers and necrotic lesions); * severe concomitant pathology with life expectancy \<1 year; * infectious diseases, history of cancer, or suspected malignancy;

Keywords: pad cli stage 2a-3 of pokrovsky-fonteine
accuracy of pulse oximeters with profound hypoxia

Conditions: Oximetry

Summary: to test the accuracy of a non-invasive blood oxygen saturation monitor which is placed on a subject with profound hypoxia.

a radial arterial cannula was placed in either the left or right wrist of each subject for arterial blood sampling and blood pressure monitoring. blood gas analysis to determine oxyhemoglobin saturation (sao2)was performed using an abl-90 multi-wavelength oximeter (hemoximeter, radiometer, copenhagen, serial 1393-090r0359n0002). this instrument contains factory certified calibration standards and quality control algorithms. each subject had two control blood samples taken at the beginning of each experiment, while breathing room air. hypoxia was then induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide. each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable. two arterial blood samples were then obtained, approximately 30 seconds apart. each stable plateau therefore was maintained for at least 60 seconds with spo2 fluctuating by less than 2-3%. the plateaus were nominally at 100%, room air saturation, 93%, 90%, 87%, 85%, 82%, 80%, 77%, 75% and 70%. a total of 270 samples were obtained at the saturation plateaus across this span. data were provided for analysis. at least 200 data points were collected for each type of oximeter and probe combination studied. pulse oximeter data is taken as 5 second averages corresponding to the point of arterial blood analysis. individual data points may be missed or excluded for dropped signals or failure of the oximeter signal to achieve an appropriate plateau. data is plotted as hemoximeter data (sao2) vs. pulse oximeter bias (spo2 - sao2). a different marker is used for each study subject. linear regression is shown for all subjects combined, and the equation with r2 is shown on the plot. mean bias is displayed as a solid horizontal line, and the upper and lower limits of agreement (mean bias ± 1.96•sd\*) are shown by dashed horizontal lines. for the "pooled" plots, different markers are used for each pulse oximeter. tables of mean, standard deviation, standard error, minimum, maximum, 95% confidence interval, count and root mean square are provided for each oximeter's bias, and all oximeters combined in the following ranges of sao2 (hemoximeter): 60 - 80%, 80 - 100%, 60 - 100%, 70 - 100%, 50 - 60%, 60 - 70%, 70 - 80%, 80 -90%, and 90 - 100%.

Eligibility criteria:
inclusion criteria: * normal hemoglobin levels (hemoglobin ≤ 10gm•dl-1) * healthy * non-smoking individuals * 21-49 exclusion criteria: * unhealthy
safety and tolerability of qva149 (indacaterol/glycopyrrolate) compared to placebo and to indacaterol in patients with moderate to severe stable chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: an investigational inhalation product (qva149) for the treatment of patients with chronic obstructive pulmonary disease (copd) is being developed. this 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.


Eligibility criteria:
inclusion criteria: * consented male or female adults aged ≥40 years * moderate to severe stable chronic obstructive pulmonary disease (copd) according to the global initiative for chronic obstructive lung disease (gold) guidelines (2006) * patients who have smoking history of at least 10 pack years * patients with a post-bronchodilator forced expiratory volume in one second (fev1) ≥30% and \<80% of the predicted normal and post-bronchodilator fev1/forced vital capacity (fvc) \<0.70 at visit 1 and visit 3 exclusion criteria: * pregnant or nursing (lactating) women * patients requiring long term oxygen therapy (\> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency room for a copd exacerbation in the 6 weeks prior to screening (visit 1) or during the screening period * patients who had a respiratory tract infection within 6 weeks of visit 1 or at screening * concomitant pulmonary disease, pulmonary tuberculosis (tb) (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis * any history of asthma * patients who have clinically relevant lab abnormalities / conditions such as (but not limited to) long term prednisone therapy, unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding stable atrial fibrillation \[af\]), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study * patients with a history of cardiac failure, life threatening arrhythmias (screening holter) and acute ischemic changes (screening ecg) * patients with a history of long qt syndrome or whose qtc (fridericia method) interval measured at screening (visit 1) is prolonged (\>450 ms for males or \>470 for females) * history of malignancy of any organ system, treated or untreated within the past 5 years * uncontrolled type i / type ii diabetes or blood glucose outside the normal range or hemoglobin a1c (hba1c) \>8.0% of total hemoglobin measured at visit 1 other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd chronic obstructive pulmonary disease indacaterol qva149
improving uptake of early infant diagnosis of hiv for the prevention of mother-to-child transmission of hiv

Conditions: HIV Infections; Acquired Immunodeficiency Syndrome

Summary: early accurate diagnosis is one of the first crucial steps in care for infants born to hiv-infected mothers. early initiation of antiretroviral therapy (art) relies upon early diagnosis and results in significant reductions in infant morbidity and mortality. there is little information on evidence-based interventions that specifically target improved attendance of postpartum clinic visits and subsequent infant hiv testing in the context of prevention of mother-to-child transmission of hiv (pmtct) programs. the investigators propose a randomized controlled trial to examine the effect of text messages sent to women enrolled in pmtct programs on adherence to postpartum clinic visits and uptake of early infant diagnosis by dna polymerase chain reaction (pcr). this study seeks to test the hypotheses that (a) text messages sent to women enrolled in pmtct will improve their attendance at the postnatal clinic within the first 6-8 weeks after childbirth; and (b) text messages sent to women enrolled in pmtct programs will increase uptake of dna pcr hiv testing at 6-8 weeks among infants exposed to hiv. this study will evaluate a novel strategy to improve adherence to postnatal clinic visits and increase the uptake of infant hiv testing. if proven superior to standard care, the proposed intervention can be easily scaled-up and integrated into existing healthcare systems in resource-limited settings. findings from this study will provide randomized trial evidence to inform hiv prevention program planners and implementers. this study will also provide further information on the feasibility of using mobile phone-based technology for public health interventions in resource-limited settings.


Eligibility criteria:
inclusion criteria: * age at least 18 years * report ability to read sms * ≥ 28 weeks gestation or delivery at study clinic on day of enrollment * hiv positive women enrolled in the pmtct program * have access to a mobile phone (personal or partner's if hiv serostatus disclosed to partner) * willing to receive sms messages from the study * planning to remain in the study area (nyanza province) for the duration of the study exclusion criteria: * age less than 18 years old * women who share phones with partners but hiv status not disclosed to partners * intention to deliver at a non-study hospital

Keywords: pmtct sms hiv infections acquired immunodeficiency syndrome prevention & control patient compliance cellular phone randomized controlled trial