Kornimate/medical-research-clean huggingface dataset:
early convalescent plasma therapy for high-risk patients with covid-19 in primary care (the cov-early study)

Conditions: Covid19

Summary: an effective, widely available, and safe treatment that can decrease the duration, severity and fatality of covid-19 is urgently needed. also, in the most affected regions the pressure on health care systems including ventilator support capacity can be a limiting factor for survival. initial studies including from our group indicate that administering convalescent plasma containing high titers of neutralizing antibodies to covid-19 patients who are already relatively late during the disease course after hospital admission is not effective, which can be explained by high titers of autologous antibodies present in patients. thus, the antiviral capacity of convalescent plasma is hypothesized to be best positioned early in the disease course and in patients at increased risk for a severe disease course. if effective, any treatment that decreases the need for hospital admission is very valuable but so far, no covid-19 treatment has been shown to prevent clinical deterioration when given before patients are admitted to the hospital. primary objective: to evaluate the efficacy, feasibility and safety following the administration of convalescent plasma (convp) as a therapy for outpatients diagnosed with covid-19 at increased risk for an unfavourable clinical outcome and within 7 days after symptom onset. study design: this trial is a nationwide multicenter, double blind, randomized controlled trial in the netherlands. patients will be randomized between the transfusion of 300ml of convp versus regular fresh frozen plasma (ffp). patient population: patients with polymerase chain reaction (pcr) confirmed covid disease with less than 8 days of symptoms, age 70 or older or 50-69 years with at least 1 additional risk factor for severe covid-19 are eligible. intervention: 300ml of convp with a minimum level of neutralizing antibodies. a total of 690 patients will be included. expected duration of accrual: 18-24 months duration of follow up :day 28 for the primary endpoint

secondary (exploratory) objectives * to evaluate the impact of 300ml convp on mortality * to evaluate the impact of 300ml convp on hospital admission * to evaluate the impact of 300ml convp on admission to icu * to evaluate the impact of 300ml convp on duration of symptoms * to evaluate the impact of 300ml convp in relation to the age and clinical frailty of the patient

Eligibility criteria:
inclusion criteria: * rt-pcr-confirmed covid-19. * symptomatic (e.g but not limited to fatigue, fever, cough, dyspnoea, loss of taste or smell, diarrhea, falls or confusion) * 70 years or older or 50-69 years and 1 or more of the risk factors described in the protocol exclusion criteria: * life expectancy \<28 days in the opinion of the treating physician * patient or legal representative is unable to provide written informed consent * symptomatic for 8 days or more * being admitted to the hospital at the informed consent procedure * known previous history of transfusion-related acute lung injury * known immunoglobulin a (iga) deficiency
leader - evaluation of endotak reliance

Conditions: Ventricular Tachycardia; Ventricular Fibrillation

Summary: the objective of this study is to demonstrate the efficacy of the endotak® reliance™ defibrillation leads connected to a defibrillator or a cardiac resynchronization defibrillator from implant until 12 months.

baseline and clinical data were collected at inclusion, as were data on procedural characteristics, device implantation-related adverse events and device programming at the time of hospital discharge. patients were subsequently divided in two groups: patients who underwent vf induction at implantation or before hospital discharge(vf induction group); and patients who did not undergo vf induction (untested group).the patients were followed up at 3-6 months and at12 months after the implantation. vf induction procedures were left to the investigator's discretion, but reasons for not performing a vf induction at implantation were recorded prospectively. icd programming parameters for tachycardia or bradycardia were also left at the investigator's discretion.

Eligibility criteria:
inclusion criteria: * icd indication according to current guidelines with or without cardiac resynchronization therapy, being implanted with a guidant endotak reliance defibrillation lead as first implant, age above 18 years, able to understand the nature of the study and to be available for all follow-ups, having given consent in writing for anonymous data collection, life expectancy \> 1 year. exclusion criteria: * device replacement without concomitant implant of a reliance defibrillation lead, pregnancy or of birth bearing age without contraception, participation in another clinical study, short life expectancy due to other medical conditions, not willing to sign the consent form, geographically unstable for a defibrillator follow-up as required per protocol, having a ventricular arrhythmia, that can be treated by drugs or surgery
interest of indocyanine green in neoplastic prostatic tissue

Conditions: Prostatic Neoplasms

Summary: prostate cancer, with more than 70,000 new cases and 8900 deaths a year in france, is a major public health problem. until 28% of patients treated with surgery will present a positive surgical margin resulting in an incomplete clearance of the tumoral process and exposing so the patient at a local, systemic recurrence and increased morbidity. an increasing number of international publications have shown (icg) was interesting for the detection of the sentinel lymph node, in the surgery of tumors of type hepatocarcinoma and liver metastases from colorectal diseases, but also in the surgery of the kidney, bladder or breast. icg has affinity for tumor and tissues around the tumor related to micro-vascular histology for a localized and specific deposit (epr effect). the detection of icg 's deposits is now possible with to the use of a device which allow to visualize the infra-red fluorescence (nir; near infra-red) for objects larger than 0.15 mm. thanks to this feature, the location of residual tumor tissue when performing a radical prostatectomy could be made much easier.

the ability of icg to detect a surgical margin positive intraoperatively has never be evaluated. we want to perform a monocentric prospective ex-vivo pilot in order to evaluate the diagnostic performance of fluorescence in the detection of surgical margins compared to pathologic analysis. this study will be conducted in 37 patients operated on for a radical prostatectomy after systemic injection of 0, 25 mg/kg of icg 24 h before the surgery. the fluorescence analysis will be performed in the operation room and then specimen will be sent to the laboratory for an analysis as usual. two pieces of prostate will be prelevated according to a protocol. the histopathological procedure will be performed without knowledge of fluorescence analysis. except the icg injection the medical procedure won't be changed.

Eligibility criteria:
inclusion criteria: * patients with prostatic cancer proved by biopsy and needing total prostatectomy with or without curettage. * patient affiliated to a social security scheme * patient has given its informed consent exclusion criteria: * contra-indication to surgery * non confirmed adenocarcinoma diagnostic * antecedent of prostatic cancer treatment * antecedent of pelvic surgery

Keywords: prostatic neoplasms prostate cancer surgical margins indocyanine green characterization prostatectomy peroperative detection
a cohort study on sleep disorders during pregnancy

Conditions: Sleep Disorder

Summary: the goal of this observational study is to: 1) determine the prevalence of sleep disorders in pregnancy and the early postpartum; 2) identify factors associated with sleep disturbance during pregnancy and the early postpartum; 3) describe the progression of sleep quality and quantity as gestational age; 4) determine if sleep is associated with adverse perinatal outcomes. participants were asked to wear a forehead sleep recorder for 4 consecutive days and to complete a sleep questionnaire at ten timepoints: at 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, and 9 months pregnant and at 1 month, 2 months and 3 months postpartum.

there is a high incidence of sleep disturbances globally, especially among pregnant women. long-term sleep disorders seriously affect the quality life of individuals, and it becomes undoubtedly an important public health problem. studies have shown that sleep disorders during pregnancy can have short-term and long-term adverse effects on both mothers and their babies. in addition, sleep during pregnancy exhibits different characteristics at different stages. most of the existing studies are based on the overall development trend to study sleep characteristics, ignoring potential individual differences. based on the concept of precision medicine, this study intends to establish a cohort focusing on the sleep health of pregnant women, and carry out continuous home sleep monitoring of pregnant women from both subjective and objective perspectives. the aim of this study is, firstly, to explore the longitudinal change characteristics, potential classification and influencing factors of sleep during pregnancy; secondly, to analyze the differences in maternal and infant adverse outcomes among pregnant women with different sleep development trajectories. the final goal is to reveal the exposure window of maternal and infant adverse outcomes caused by sleep, thus improving the accuracy of outcome prediction, and promoting the development of accurate and personalized sleep management programs.

Eligibility criteria:
inclusion criteria: 1. gestation age ≤ 13 weeks + 6 days 2. 20 years old ≤ age ≤ 40 years old 3. singleton pregnancy 4. give informed consent and able to participated exclusion criteria: 1. unmarried, divorced or widowed 2. women who suffered severe physical or mental illness 3. women who suffered death, abortion, stillbirth or neonatal death during the study 4. women who are participating in other studies 5. other reasons
assessing social determinants of health to increase cancer screening

Conditions: Lung Cancer

Summary: a multilevel lung screening intervention that pairs social determinants of health (sdoh) screening and referral with a tailored health communication and decision support tool for lung screening has the potential to significantly impact lung screening uptake among at-risk individuals in the community, particularly among those who face barriers related to sdoh. in addition, findings will advance the understanding of effective strategies for improving lung screening and prevention efforts in non-traditional settings, with the ultimate goal of reducing the burden of lung cancer. as ways to support the realization of the public health benefit of lung cancer screening are considered, multiple strategies and venues to reach, and intervene, with screening-eligible is key. the goal of this study is to compare the effectiveness of a community-based lung screening educational tool paired with a social determinants of health (sdoh) screening assessment and referral process compared to a community-based lung cancer screening (lcs) educational tool alone as part of community outreach activities to improve (a) lcs rates (primary outcome); (b) intention to screen; and (c) individual-level potential drivers of lcs (health literacy, mistrust, stigma, fatalism, knowledge, health beliefs). it is hypothesized that providing sdoh screening and referral will result in higher levels of lcs, forward movement of intention to screen, and improved individual-level drivers of lcs.

the study will be a pilot randomized controlled trial (rct) to compare primary (lcs uptake) and secondary outcomes (intent to screen, literacy, mistrust, stigma, fatalism, health beliefs) among lcs-eligible men and women in new jersey community-based settings who receive a community-based lcs educational tool paired with a social determinants of health (sdoh) screening assessment and referral process (n=50) compared to a community-based lcs educational tool alone (n=50) as part of community outreach activities. all individuals who attend a community event are normally assessed for cancer risks and appropriate cancer screening education is provided. for those who are eligible for lcs, they will also be invited to participate in this study.

Eligibility criteria:
inclusion criteria: * aged 50 years to 80 years * currently smoke or quit smoking within the past 15 years * 20 pack-year smoking history * has never had lung cancer screening * able to provide informed consent * able to speak and understand english exclusion criteria: * diagnosed with lung cancer * has a history of having a lung cancer screening scan * unable to speak and understand english

Keywords: screening social determinants of health lung cancer screening
the impact of long-term pessary use on pelvic organ prolapse oìduring covid-19 pandemic in patients attending surgery

Conditions: Pelvic Organ Prolapse; Vaginal Prolapse

Summary: patients aged 45 to 80 years with a clinical diagnosis of stage iii and iv genital prolapse involving the anterior and/or middle compartments and candidates for surgery will be considered. these will be evaluated to observe whether there is improvement in clinical prolapse with the use of the vaginal pessary during the waiting period for surgery


Eligibility criteria:
inclusion criteria: * pelvic organ prolapse with pop-q stage \>/= 3 in anterior and/or central compartments * women between 45 and 80 years old exclusion criteria: * women who refuse to participate in the study * patients without baseline popq examination documented or with a pessary previously positioned * previous pelvic surgeries * women with any contraindication for surgery or preference for conservative treatment only (pelvic muscle exercise, vaginal pessary) * women who are not successfully fitted with pessaries * current genital ulcers/infections * active or chronic pelvic infection * women who are mentally incapable of completing the questionnaires.
efficacy of beraprost in lowering pulmonary arterial pressure in children

Conditions: Pediatric Pulmonary Hypertension

Summary: to analyze the efficacy of beraprost and sildenafil for treatment of pulmonary hypertension in children with left to right shunt. analyze the efficacy and side effects.

eligibility criteria: inclusion: 1. children aged 1-17 years with left to right shunt, diagnosed as pulmonary hypertension. 2. free from chronic pulmonary disease 3. never performed any cardiac surgical 4. never got any treatment for ph 5. agree to enroll in this study. exclusion 1. suffer from portal hypertension, hiv and connective tissue disease 2. under interferon therapy. outcome measure: pulmonary artery pressure

Eligibility criteria:
inclusion criteria: * diagnosed as pulmonary hypertension with left to right shunt chd (vsd, asd, pda and combination) * agree to enroll in this study exclusion criteria: * suffer from chronic lung disease * suffer from soft tissue tumor, hiv/aids * under interferon therapy * already performed any cardiac surgery * already got anti-ph remedy
does microglial activation promote lesion growth and progression among multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to assess whether increased microglial activation (measured using tspo-pet) at lesion rim is associated with more rapid lesion growth during 10 year follow up.

objective: to evaluate individual ms lesions and their growth during a total of 10 year follow-up after initial positron emission tomography (pet) -imaging with pk11195 or tmsx radioligands. background: focal inflammatory lesions in the white and grey matter of the central nervous system represent the best characterized pathological phenomena of ms disease. some ms lesions slowly expand over time. neuropathological studies have detected inflammatory rim formed by activated microglia cells around some ms lesions and it has been suggested that the presence of the inflammatory rim could predict lesion expansion. our hypothesis is that the lesions with higher tspo or tmsx radioligand binding at the initial pet scan will expand more during the total of 10-year follow up compared to those lesions with lower radioligand binding. this longitudinal follow-up study will provide a more complete picture of the association of the innate immune cell activation, lesion growth and disease progression. study population: the research will recruit approximately 100 ms-patients who have taken part to our previous pet-imaging ms studies in turku pet centre. the research interventions will consist of magnetic resonance imaging (mri) scans, blood sampling, clinical neurological evaluation and patient-reported outcome measures (filling forms).

Eligibility criteria:
inclusion criteria: * participation to a previous pet imaging study of airas group * ms diagnosis exclusion criteria: * patients with other neurodegenerative disease than ms * contraindication to mr scan investigations * patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
study of prophylaxis, activity and effectiveness (space) in hemophilia patients currently treated with advate or rixubis

Conditions: Hemophilia A; Hemophilia B

Summary: this 6-month prospective outcomes study addresses the association between timing of infusion, patient activity levels, and bleeding episodes through patient-reported measurements.


Eligibility criteria:
inclusion criteria: * 13 to 65 years old at the time of screening * has moderately severe or severe hemophilia a or b (fviii/fix level ≤2%), with or without transient inhibitors * hemophilia a patient currently prescribed advate (fviii) or hemophilia b patient currently prescribed rixubis (fix) * previously treated with plasma-derived fviii/fix concentrates or recombinant fviii/fix for ≥150 documented exposure days (eds) * is willing and able to comply with the requirements of the protocol * is proficient in the english language to allow for use of the space ediary exclusion criteria: * inhibitor titer ≥0.6 bethesda units or currently being treated for an inhibitor * has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of this study * is a family member or employee of the investigator * elective major surgery is planned within 6 months after enrollment which may interfere with activities of daily living (at investigator's discretion) * continuously require walking assistance devices (eg, wheelchair, crutches, etc.)

Keywords: factor viii deficiency factor fix deficiency
involvement of the mediodorsal nucleus of the thalamus in higher order cognitive processes

Conditions: Thalamic Infarction

Summary: the aim is to expand evidence about the importance of the mediodorsal nucleus of the thalamus as a key node in human higher-order cognitive functions such as learning, decision-making, and adaptive behavior. thus, the project proposes to assess global cognition along with higher-order cognition integrity via sensitive behavior tasks in patients with well localized lesions (mediodorsal thalamic infarcts) compared with healthy participants.

the recruitment of patients with isolated thalamic lesion after stroke is known to be a challenge that the investigators overcame through the expertise of neurologists within their stroke unit. first, they will describe the cognitive profile consecutive to a lesion of the thalamus, assessed with standardized neuropsychological tests. second, and more specifically, they will study performances at experimental tasks focusing on higher-order cognition (decision-making, updating, interference managing, multitasking). they will use the automatic localization method already performed : the lesions will be manually segmented from t1 morphologic sequences, and then normalized in a template. finally a numerical atlas of thalamus will be applied on the lesions, determining the injured substructure and the lesion volume. besides, this method will be compared with new high resolution thalamus-centered anatomical sequences allowing direct and individual identification of the involved thalamic nucleus.

Eligibility criteria:
inclusion criteria for patients: * french as their mother tongue * absence of cognitive deterioration before the stroke. * visual, auditory (equipment authorized) and oral or written skills sufficient for the proper assessment using neuropsychological tests. * first infarct affecting the thalamus. * at least seven years' schooling from primary school * signed informed consent * chronic lesion (\> 3 months) inclusion criteria for controls: * french as their mother tongue * absence of cognitive complain * visual, auditory (equipment authorized) and oral or written skills sufficient for the proper assessment using neuropsychological tests. * at least seven years of school from primary school * signed informed consent exclusion criteria for patients: * neurological deficit or significant residual disability at inclusion. * aphasia, agnosia, apraxia or severe neglect, as demonstrated by clinical examination and neuropsychological tests. * subjects with a contraindication to mri. * general, neurological or psychiatric progressive disease. exclusion criteria for controls: * subjects with a contraindication to mri. * general, neurological or psychiatric progressive disease.

Keywords: mediodorsal nucleus higher order cognition
split face study of the duration of local anesthetics

Conditions: Anesthetics, Local

Summary: this is a research study to compare how long injectable pain medications (anesthetics) commonly used in dermatologic surgery are effective for. this study will compare a short-acting anesthetic, lidocaine with epinephrine, to one of two long-acting anesthetics (ropivacaine or bupivacaine). this study will also directly compare the duration of actions of ropivacaine and bupivacaine. the investigators hypothesize that the duration of anesthesia of short-acting anesthetics will not differ significantly from long-acting anesthetics at a single site and there will not be a significant difference between the two long-acting anesthetics at a single site.

this study will compare the relative durations of local anesthetics within the same subject at a highly vascularized anatomic region of skin, the nasal ala. this study will test and compare the relative durations and efficacy of commonly used long acting (ropivacaine or bupivacaine) and short acting local anesthetics (lidocaine with epinephrine), delivered via local anesthesia. this study will use a modification of a previously published approach of non-invasive pinprick testing to assess the duration of local anesthetic.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * normal skin sensation at both nasal ala assessed by pinprick * ability to provide informed consent exclusion criteria: * previous adverse reaction to local anesthetic or any components of the local anesthetics being evaluated * pregnant or breastfeeding volunteers (assessed by self-report) * patients taking monoamineoxidase inhibitors (maoi) or antidepressants of the triptyline or imipramine types

Keywords: anesthesia mohs lidocaine ropivacaine bupivacaine