Kornimate/medical-research-clean huggingface dataset:
interaction between early trauma and odor-induced dopamine release

Conditions: Trauma, Psychological

Summary: this prospective, double-blind, parallel-group controlled trial aims to investigate the consequence of early trauma on dopamine release evoked by positive valence odors.

the occurrence of early trauma has been linked to alterations in the development of emotion regulation circuits and functional brain connectivity (particularly in the dorsolateral prefrontal cortex - dlpfc), the dopaminergic response to stress and an alteration in hedonicity (including olfactory hedonicity), which can lead to the onset of psychiatric disorders such as anxiety or depression. however, few studies have investigated the influence of early trauma on the release of dopamine (da) evoked by odors with a positive emotional valence. yet hedonicity is a key component of olfaction, as a positive odor leads to reinforced behavior in areas such as food intake and social interaction. this reinforcement process is thought to be underpinned by the very close link between the olfactory system (olfactory tubercle), the emotional regulation system (dlpfc) and the reward system (striatum), including the release of da. the aim of the study is to investigate the influence of early trauma on daergic transmission evoked by odorants with a positive emotional valence. to this end, 30 participants will be recruited and divided into two groups: those with early trauma and those without, according to their score on the childhood trauma questionnaire. they will undergo an mri-pet scan during which they will be exposed to pleasant odors. subcortical dopaminergic transmission will be analyzed using the pet activity of \[11c\]raclopride (a d2 receptor antagonist). investigators hypothesize that early trauma resulting in abnormal cortico-subcortical and cortico-cortical connectivity would lead to a deficit in the hedonic appreciation of a pleasant odor, associated with a reduction in daergic reactivity evoked in the reward system.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * have been selected based on the childhood trauma questionnaire score * non-smoker * be able to speak and read french * sign a consent form before intervention. exclusion criteria: * a pre-existing condition that affects olfaction including congenital anosmia, upper respiratory tract infection, nasal and/or sinus disease, * be on medication, with the exception of oral contraceptives * pregnant or breast-feeding woman (check with urine pregnancy tests); * contraindications to tms or mri (implanted medical devices or metallic foreign body in the head); * psychiatric disorders * use of psychotropic drugs * have participated in a study involving the injection of a radiotracer during the year
a comparison of the drug therapy versus re-ablation

Conditions: Paroxysmal Atrial Fibrillation; Failed First Radiofrequency Ablation Procedure

Summary: the hypothesis of this study was that early re-ablation (test) was superior to aad therapy (control) in patients with previous failed pvi ablation for paroxysmal af.


Eligibility criteria:
inclusion criteria: * history of symptomatic paf exclusion criteria: * congestive heart failure * lv ejection fraction \< 35% * left atrial diameter \> 60 mm

Keywords: atrial fibrillation arrhythmias anti-arrhythmic agents
alveolar dead space as predictor of organ failure in severe sepsis

Conditions: Sepsis; Severe Sepsis; Septic Shock; Multi-organ Failure

Summary: this is an observational study to understand the changes in alveolar dead space in medical critically ill patients with severe infection (severe sepsis) requiring mechanical ventilation and the possibility to predict multi-organ failure. the measurement of alveolar dead space used to require sophisticated equipment and time. new ventilators have microprocessors that allow rapid mathematical calculation with minimal intervention.

the patient will be followed during their icu stay up to two weeks while on mechanical ventilation. patient will be followed daily for the initial 48 hours and then once per week for 2 weeks while mechanically ventilated.

Eligibility criteria:
inclusion criteria: * adults with severe sepsis or septic shock on mechanical ventilation * enrolled in the initial six hours of icu admission exclusion criteria: * patients with withdrawal or hospice order. * patients with terminal, irreversible disease, expect to decease in 48 hours from icu admission. * patients with copd. * patients transferred from outside icu with ongoing sepsis management for more than six hours.

Keywords: sepsis severe sepsis septic shock alveolar dead space multi-organ failure
controlled trial of angiotensin receptor blocker (arb) & chemokine receptor type 2 (ccr2) antagonist for the treatment of covid-19

Conditions: COVID-19; SARS-CoV2 Infection

Summary: clarity 2.0 is an investigator-initiated trial that will evaluate the safety and efficacy of dual treatment with repagermanium, a ccr2 antagonist, and candesartan, an arb, in patients hospitalised with covid-19 disease.


Eligibility criteria:
inclusion criteria: 1. adults aged ≥ 18 years (maximum 65 years old in india). 2. laboratory-confirmed diagnosis of sars-cov-2 infection within 10 days prior to randomisation. (confirmation must be through reverse transcription polymerase chain reaction \[rt-pcr\] method) 3. intended for hospital admission for management of covid-19. 4. patients with moderate (respiratory rate of ≥ 24/minute or spo2: 90% to ≤ 93% on room air) or severe (respiratory rate of ≥ 30/minute or spo2: \<90% on room air) covid-19. 5. systolic blood pressure (sbp) ≥ 120 mmhg or sbp ≥ 115 mmhg and currently treated with a non-raasi bp lowering agent that can be ceased. 6. willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments. 7. documented informed consent. exclusion criteria: 1. currently treated with an acei, arb or aldosterone antagonist, aliskiren, or arni 2. intolerance of arbs 3. serum potassium \>5.5 mmol/l 4. an estimated glomerular filtration rate (egfr) \<30ml/min/1.732m 5. known biliary obstruction, known severe hepatic impairment (child-pugh-turcotte score 10-15) 6. pregnancy, lactation, or inadequate contraception. 7. participation in a study of a novel investigational product within 28 days prior to randomisation. 8. plans to participate in another study of a novel investigational product during this study.

Keywords: covid-19 sars-cov2 angiotensin receptor blocker (arb) c-c chemokine receptor type 2 (ccr2) antagonist
long-term follow-up of patients with chronic kidney disease who had administered cellgram-ckd in pmc-p-12 study

Conditions: Renal Insufficiency, Chronic

Summary: this long-term follow-up study is a 5-year long-term follow-up study to evaluate long-term safety in cellgram-ckd subjects. (refer to clinicaltrials.gov.identifier: nct05042206).

this long-term follow-up study is a 5-year long-term follow-up study to evaluate long-term safety in cellgram-ckd subjects. (refer to clinicaltrials.gov.identifier: nct05042206). the long-term safety of cellgram-ckd is evaluated by monitoring whether or not an adverse event of special interest (aesi) occurs for 5 years from the date of administration in cellgram-ckd subjects who voluntarily consented in writing to participate in the long-term follow-up study.

Eligibility criteria:
inclusion criteria: * those who participated in the pmc-p-12 clinical trial and received cellgram-ckd * subjects who consented in writing to this long-term follow-up study exclusion criteria: * not applicable
mri investigations in attention deficit hyperactivity disorder (adhd) and high potential (hp) children for a better therapeutic approach

Conditions: ADHD

Summary: impulsivity and/or hyperactivity in children has become one of the main clinical symptom for consultation, among the most frequent, in general or pediatric medicine. among the different clinical forms of instability, adhd appears to be an especially disabling condition for the development of the child, both in psychomotor, cognitive, emotional and relational aspects. further, a significant link between adhd children and some children with high potential (hp) is observed. hp children show overall ahead cognitive developments compared to children with the same age. in these children, as well as in children with adhd, an attention vulnerability, psychomotor deficits are noted, as well as emotional and relational deficits that significantly contrasted with some of their cognitive skills. regarding the hp, the hypothesis is that children with significantly heterogeneous results (complex) to the wechsler iv scales are affected by this shift, and hence, by the difficulty of a differential diagnosis with adhd, unlike those whose intelligence quotient (iq) results that are more homogeneous (laminar). the goal of this work was to study a population of 80 children aged from 8 to 12 years (20 subjects per group) to evaluate the functional and structural brain development by: * functional magnetic resonance imaging (fmri) acquisitions with cognitive stimulations, involving attention, working memory and semantic processing, and emotional stimulations, * fmri acquisitions at rest (without activation), * diffusion tensor magnetic resonance imaging (dti) acquisitions, * 3d anatomic acquisitions. identification of developmental differences in certain cortical brain areas (eg, prefrontal vs parietal), white matter fiber bundles or functional networks preferentially used by one or other of these groups, will help to better understand this disease, and to improve the differential diagnosis in order to implement a more appropriate and personalized management of the patients via new therapeutic strategies.


Eligibility criteria:
inclusion criteria: * right-hand 4 groups : * laminar hp : iq \> 130 and difference between verbal comprehension index (vci) and perceptual reasoning index (pri) \< 9 * complex hp : iq \> 130 and difference between vci and pri \>15 * adhd : 90 \< iq \<110 * controls : 90 \< iq \<110 exclusion criteria: * subjects with any psychiatric disorders except adhd, * subjects with known learning deficits (dyslexia, dysphasia...), attention deficits except for adhd group * subjects with claustrophobia or magnetic devices * children with out both parental agreements

Keywords: laminar hp complex hp
a study of ast-120 for evaluating prevention of progression in chronic kidney disease (eppic-1)

Conditions: Chronic Kidney Disease

Summary: 1) to evaluate the effectiveness of ast-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe chronic kidney disease (ckd), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (scr) when compared with placebo; 2) to evaluate the safety and tolerability of long-term ast-120 therapy in patients with ckd; 3) to evaluate the effects of ast-120 versus placebo, on other measures of renal function.


Eligibility criteria:
inclusion criteria: * age 18 years or older * moderate to severe ckd, not anticipated to require dialysis or renal transplant within the next 6 months * patient survival expected to be no less than one year * serum creatinine in men \>= 2.0 mg/dl (\>= 177 µmol/l) and \ = 1.5 mg/dl (\>= 133 µmol/l) and \<= 5.0 mg/dl (\<= 442 µmol/l) at screening * urinary total protein to urinary total creatinine ratio must be \>= 0.5 on a spot void at screening * blood pressure \ 160/90 mmhg * in patients being treated for hypertension, they should be on a stable anti-hypertensive regimen exclusion criteria: * obstructive or reversible cause of kidney disease * nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine of \> 6.0 as measured on a spot void * adult polycystic kidney disease * history of previous kidney transplant * history of recent (within the past 6 months) accelerated or malignant hypertension * uncontrolled arrhythmia or severe cardiac disease within the past 6 months * history of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, or severe gi dysmotility, not attributable to the use of a phosphate binder * received any investigational agent or participated in a clinical study within the previous 3 months * presence of any significant medical condition that might create an undue risk with study participation, or significantly confound the collection of safety and efficacy data in this study

Keywords: kidney diseases
antibacterial effectiveness of two root canal irrigants

Conditions: Periapical Periodontitis

Summary: the aim of this randomized clinical trial is to compare the antibacterial effects of 1% sodium hypochlorite (naocl) and 2% chlorhexidine gluconate (chx) during retreatment of teeth with apical periodontitis (ap).

root canal-treated teeth with ap were randomly distributed in two groups according to the irrigant used. after removal of the previous filling material, bacteriological samples were taken from the canals before (s1) and after chemomechanical preparation using either naocl or chx (s2), and after calcium hydroxide medication for 2-3 weeks (s3). 16s rrna gene-based real-time qpcr was performed to detect and quantify total bacteria, streptococcus species and enterococcus faecalis.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of apical periodontitis in a root-filled tooth assessed by radiography. exclusion criteria: * presence of gross carious lesions in the diagnosed tooth, * presence of fractures involving the periodontium of the diagnosed tooth, * presence of periodontal pockets more than 4 mm deep in the diagnosed tooth, * diagnosis of diabetes, * diagnosis of hiv infection, * other immunocompromising disease, * antibiotic therapy within the previous 3 months.

Keywords: endodontic retreatment sodium hypochlorite chlorhexidine calcium hydroxide retreatment
evaluation of thoracolumbar interfascial plane block for postoperative analgesia after herniated lumbar disc surgery

Conditions: Postoperative Analgesia After Disc Surgery

Summary: several regional anesthesia have been shown to improve postoperative outcomes in many studies. the transversus abdominis plane (tap) block provides anesthesia to the abdominal wall by introducing local anesthetic to the anterior rami of the spinal nerve roots. this work evaluates the analgesic effects gained after performing thoracolumbar interfacial plane block (analogous to the tap block but intended for the back) which targets the sensory component of the dorsal rami of the thoracolumbar nerves in patients undergoing back surgeries.


Eligibility criteria:
inclusion criteria: * patients with asa 1 or 2 aged between 21years old up to 60 years old of both sex scheduled of back surgery exclusion criteria: * exclusion criteria will be patients refusal or inability to give an informed consent , history of relevant allergy to any of the drugs used in the procedure , previous lumbar spine surgery or back surgery with planed spinal fixation.
an observational study of respiratory syncytial virus (rsv) hospitalizations in preterm infants

Conditions: Respiratory Syncytial Virus Hospitalizations

Summary: purpose of this study is to evaluate clinical, humanistic and health economic burden of respiratory syncytial virus (rsv) in infants born 29 to 35 weeks gestational age (wga) hospitalized for rsv at up to 12 months of age.

this surveillance study will enroll approximately 500 eligible infants from approximately 40 study sites in the us, hospitalized for laboratory-confirmed, nosocomial or community-acquired rsv disease during the study eligibility period of 1 october 2014 through 30 april 2015 (season 1) and 1 october 2015 through 30 april 2016 (season 2). during these eligibility periods, infants may be enrolled: * prospectively at the time of their index respiratory syncytial virus hospitalization (rsvh) admission or any time prior to their index rsvh discharge, or * retrospectively on the basis of electronic medical record (emr) review following discharge from the index rsvh. regardless of the timing of study enrollment (i.e., in relation to the date of discharge from the index rsvh), sites will identify all infants eligible for study participation, including those treated in the inpatient ward and intensive care unit (icu). identification of all potentially eligible infants will be ensured through the review of the emr, or other local healthcare database deemed appropriate for study purposes by the study coordinating center (scc). the clinical, humanistic and health economic outcomes associated with the rsv disease will be characterized in the outpatient and inpatient settings, from the onset of symptoms of rsv disease pre index rsvh to up to 4 months post index rsvh discharge date (additionally to 12 months post index rsvh discharge date in season 1 only), on the basis of medical records and parent/guardian self-report. information regarding any sequelae associated with the index rsvh, medically-attended wheezing episodes, loss of work productivity and healthcare resource utilization (hru) related to the management of rsv-related disease will also be collected from the medical records and parent/guardian by telephone interview at approximately 1 month and 4 months following discharge from the index rsvh (additionally at 12 months in season 1 only).

Eligibility criteria:
inclusion criteria: * born at 29 to 35 wga (i.e., 29 weeks, 0 days through 35 weeks, 6 days) * laboratory-confirmed, nosocomial or community-acquired rsv disease (rsv can be documented in the outpatient and/or inpatient setting during the illness that resulted in the index hospitalization) * hospitalized ≥24 hours for the diagnosed rsv disease (the index rsvh) * \<12 months of age at time of index rsvh admission * written informed consent and any locally required authorization (e.g., hipaa), obtained from the infant's parent/guardian exclusion criteria: - receipt of rsv immunoprophylaxis within the 35 days prior to onset of respiratory symptoms associated with the index rsvh

Keywords: rsv rsvh infant gestational age wga preterm
anti-anxiety biotics for breast cancer survivors

Conditions: Anxiety Generalized; Breast Cancer Female

Summary: cancer survivors experience more rapid declines in health-related quality of life which include physical and psychological comorbidities, the latter of which may be subclinical and often overlooked by primary care providers. recently, the gut-brain axis (gba) has been identified as a therapeutic target to improve host health. the gba is greatly influenced by the composition of the gut microbiome, as microbial metabolites directly influence the central nervous system. thus, prebiotics, probiotics, and synbiotics (a combination of pre- and probiotics) have emerged as a possible approach to treating anxiety symptoms. preclinical studies suggest efficacy of synbiotics, while pre- and probiotics have only been studied in isolation in humans. this is a double-blind, placebo-controlled clinical trial in which female breast cancer survivors and/or their female relatives experiencing moderate to severe anxiety symptoms will be randomized to daily consumption of the synbiotic supplement or placebo. the previously validated generalized anxiety disorder-7 (gad-7) will be used to assess anxiety symptom severity at study screening and at each time point. the primary outcome of this study is feasibility, measured by accrual, adherence, retention, and adverse effects. secondary outcomes relate to reduction of anxiety symptoms and other physiological changes. no study has investigated the mediating effects of gut microbiota and inflammatory markers on the ability of synbiotics to reduce anxiety symptoms. thus, at each timepoint, phlebotomy will be conducted to determine serum levels of inflammatory cytokines and stool samples will be collected to determine alpha- and beta-diversity of the fecal microbiome as well as relative abundance of target genera. hypothesis: this placebo-controlled study will be feasible and synbiotic treatment will result in a significant reduction in anxiety symptoms and inflammatory markers, which may be moderated by changes in the microbiome.


Eligibility criteria:
inclusion criteria: female breast cancer survivors or female relatives of a breast cancer survivor who: 1. are 50 years of age or older 2. have completed primary treatment 3. currently experience clinical anxiety symptoms determined by the 7 item generalized anxiety disorder screener (gad-7; eligibility requires a total score of 5 or higher on the 21 point scale) 4. agree not to change dietary supplements throughout the course of the study 5. are willing to comply with daily supplement regimen 6. are able to speak and read english. exclusion criteria: 1. use of any of the following drugs within the last 4 weeks (unless indefinitely prescribed): systemic antibiotics, corticosteroids, immunosuppressive agents, or commercial probiotics 2. changes in treatment for anxiety symptoms (i.e. initiation of cognitive behavior therapy (cbt) within the last four weeks 3. current use (within 12 weeks) of anxiolytic medications.
ibuprofen and acetaminophen versus ibuprofen and acetaminophen plus hydrocodone for analgesia after cesarean section

Conditions: Opioid Use; Pain, Postoperative

Summary: postpartum patients delivered by cesarean section will be randomized to nsaids vs nsaids plus opioid

women will be approached priors to discharge from the hospital, if they meet inclusion criteria and consent for the study, they will be randomized to one of two possible analgesic regimens. they will be followed at 1-2 weeks and 4-6 weeks after discharge to assess pain level.

Eligibility criteria:
inclusion criteria: * english or spanish speaker women who had a cesarean section exclusion criteria: * inability or refusal to provide informed consent. * reported current or prior opioid or benzodiazepine use disorder, including urine drug screen positive for a non prescribed opioid or benzodiazepine upon admission or during prenatal care. * current treatment with methadone, buprenorphine or buprenorphine plus naloxone. * known alcoholism disorder. * severe renal or hepatic impairment. * known creatinine \> 1.5 at the time of delivery or severe proteinuria leading to diagnosis of renal disease prior to delivery. * severe peptic ulcer disease * severe asthma (if patient has asthma but has previously tolerated nsaids, she will be allowed to participate) * known cyp450/cy92d6 mutation conferring opioid ultra-rapid metabolizer status. * allergy to any of the study drugs (anaphylaxis). * incarcerated or institutionalized patients. * inability to follow up as outpatient in our outpatient clinic. * wound dehiscence or infection diagnosed prior to discharge from the hospital * wound vac placed prior to discharge from the hospital

Keywords: postpartum