Kornimate/medical-research-clean huggingface dataset:
safety, tolerability, pharmacokinetics, and pharmacodynamics of mrna-1944 in healthy adults

Conditions: Prevention of Chikungunya Virus Infection

Summary: this is a phase 1, fih, single-center, randomized, placebo controlled, dose escalation study to evaluate the safety, tolerability, pk, and pd of mrna-1944 in healthy adult subjects. cohorts of mrna-1944 are planned to be investigated in a sequential dose escalation manner.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 and ≤ 50 years of age * weight of 50 to 100 kg, inclusive * in good general health as determined by medical history, clinical laboratory assessments, ecg results, vital sign measurements, and physical examination findings at screening * has access to consistent and reliable means of contact and agrees to stay in contact with the study site for the duration of the study exclusion criteria: * any acute or chronic clinically significant disease, as determined by physical examination or laboratory screening tests * elevated liver function tests or safety laboratory test results * positive screening test for the presence of anti-chikv igg * administration of another investigational study involving any investigational product within 60 days or 5 half-lives, whichever is longer * has received any live attenuated or inactive vaccines within 4 weeks prior to check-in, or plans to receive any vaccine during the study * known or suspected immune-mediated disease or immunosuppressive condition (including lymphoproliferative disorders) * any neurologic disorder * history of idiopathic urticaria * any bleeding disorder that is considered a contraindication to study drug infusion or blood collection * receipt of immunoglobulins, a monoclonal antibody or any blood products within the preceding 6 months * any acute illness at the time of enrollment * a positive test result for drugs of abuse * a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus type 1 or 2 antibodies * a history of active cancer (malignancy) in the last 3 years * donation of ≥ 450 ml blood or blood products within 30 days of study drug infusion

Keywords: chikungunya fever alphavirus infections togavirus viral diseases
development of a tissue-based & cell free dna next-generation sequencing workflow

Conditions: Non-Hodgkin Lymphoma

Summary: 1. develop a next-generation sequencing (ngs) workflow for mutation profiling of formalin-fixed paraffin-embedded (ffpe) tissue and cell-free dna (cfdna) specimens. 2. calculate the proportion of cases in a test series of b-cell non-hodgkin lymphomas (bnhl) with somatic mutations or immunoglobulin heavy chain (igh) gene rearrangements common to both fppe and cfdna specimens. 3. determine if certain types of bnhl are more likely to have mutation profiles common to both ffpe \& corresponding cfdna ("ffpe-cfdna dyads") 4. determine if specific mutations or mutation profiles in ffpe or cfdna specimens (or both) are of prognostic value after a clinical follow-up of 2 years from the time of diagnosis.

patients with newly diagnosed b cell nhl will be identified. samples will be cored from their diagnostic ffpe blocks and assayed to find lymphoma specific variants and immunoglobulin heavy chain gene rearrangements. blood samples collected at baseline will be compared to see if variants and rearrangements can be detected in tumor specific dna based on previous studies. participant data will be collected, and clinical outcomes will be assessed to determine effect of mutation profiles on outcomes over 2 year follow up. blood samples will be prospectively collected at scheduled follow up and if primary objectives of this study are met, will be assessed for presence of cfdna and impact of variation on clinical outcomes.

Eligibility criteria:
inclusion criteria: * new diagnosis of b cell nhl * willing to have blood collected at timepoints of regularly scheduled follow up * formalin fixed paraffin embedded (ffpe) diagnostic specimen sufficient for further testing exclusion criteria: * unwilling or unable to participate in follow up

Keywords: next generation sequencing cell free dna
early oral fluid intake in children after day surgery

Conditions: Pediatric Anesthesia; Postoperative Nausea and Vomiting (PONV); Ambulatory Surgical Procedures

Summary: this study investigates the safety and tolerability of early oral clear fluid intake in children aged 1-8 years undergoing elective outpatient non-gastrointestinal surgeries. patients will be randomized to receive clear fluids either at 1 hour or 2 hours after general anesthesia. the goal is to determine whether earlier fluid intake increases the risk of postoperative vomiting (pov), or whether it can be safely tolerated in pediatric patients."

this prospective, randomized controlled clinical trial aims to evaluate the safety and tolerability of early oral clear fluid intake in children aged 1 to 8 years undergoing elective, outpatient, non-gastrointestinal surgery under general anesthesia. recent guidelines recommend reducing preoperative and postoperative fasting durations in children to enhance recovery and well-being. early postoperative hydration has been associated with reduced opioid requirements, faster return to normal diet and ambulation, and shorter hospital stay, without increasing the risk of postoperative nausea and vomiting (ponv). in this study, participants will be randomly assigned to one of two groups. group e (early group) will receive up to 10 ml/kg of clear fluids (e.g., water, clear juice) one hour after the end of anesthesia, while group t (traditional group) will receive the same amount two hours after anesthesia. patients will be evaluated for readiness to drink based on recovery of consciousness, protective airway reflexes, and absence of nausea or vomiting. fluid will be administered slowly and under strict supervision by experienced staff, with emergency equipment readily available. the incidence of vomiting will be assessed using a modified 4-point scale. additional outcome measures include tolerability of oral fluids, time to readiness for discharge, and incidence of delayed postoperative vomiting on postoperative days 1 and 3, assessed via phone interviews with caregivers. this study seeks to provide evidence-based guidance on the optimal timing and volume of clear fluid intake in pediatric patients following ambulatory minor surgical procedures, contributing to more flexible and patient-centered perioperative fasting protocols.

Eligibility criteria:
inclusion criteria: * children aged between 1 and 8 years * asa physical status i or ii * undergoing elective, outpatient, non-gastrointestinal surgery under general anesthesia * expected to be discharged on the same day * parent/guardian provides informed consent exclusion criteria: * emergency surgeries * history of gastrointestinal disorders * history of aspiration or recurrent vomiting * children with neurodevelopmental delay * intraoperative complications requiring icu admission * refusal of oral intake postoperatively

Keywords: perioperative fasting ambulatory surgery pediatric postoperative care clear fluid intake postoperative nausea and vomiting (ponv) pediatric anesthesia
evaluation of the pharmacokinetics of caspofungin in icu patients

Conditions: Shock

Summary: although the pharmacokinetics of caspofungin has been studied in healthy subjects and patients, only a few studies have been performed in critically-ill patients. in these patients several factors, including sepsis, shock, increased distribution volume, hepatic dysfunction and hypoalbuminemia may result in dramatic changes in antibiotic concentrations and pharmacokinetics. caspofungin pharmacokinetic data is scarce and are results mainly from case series or animal studies. thus, studies performed so far show caspofungin trough concentrations either decreased, similar to usual value in non-critically ill patients or increased. one of these studies suggested that body weight and hypoalbuminemia may be the main factors associated with caspofungin pharmacokinetic variability. pharmacokinetic parameters of caspofungin in pigs with hypovolemic shock suggested the peripheral volume of distribution of caspofungin and intercompartmental clearance to be higher than in healthy animals. these results are however preliminary and cannot be extrapolated suggesting further clinical studies in human to be needed. the primary objective of this study is to assess caspofungin trough concentrations and pharmacokinetics in critically-ill patients requiring vasopressors.


Eligibility criteria:
inclusion criteria: * adult patients (age \> 18 y.o) * either preemptive, empirical or curative prescription of caspofungin by one of the icus' attending physician * requiring vasopressors * admission in one of the participating icus. exclusion criteria: * pregnancy * lack of affiliation to the national medical insurance * previous inclusion in the study * inclusion in a concomitant study that may interact with the current study

Keywords: intensive care unit shock antifungal agent pharmacokinetics sepsis
does diabetes related distress impact on balance glycemic ?

Conditions: Diabetes

Summary: the main objective is to assess the overall diabetes distress score in adult patients with diabetes during their hospitalization in a diabetes ward, using the diabetes distress scale (dds-17). the correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin will then be assessed.

the health consequences of emotional problems are associated with poor self-care behaviour, poor metabolic outcomes (hba1c) and reduced quality of life. if quarterly glycated haemoglobin (hba1c) testing is the gold standard for monitoring the risk of diabetes complications, should it not be systematically combined with the assessment of distress related to living with diabetes? to our knowledge, there are few studies in france that have correlated glycaemic control with a scale assessing the emotional stress factors associated with diabetes. the main objective is to evaluate diabetes-related distress in adult patients with diabetes during their hospitalization in a diabetes ward, using a self-assessment instrument: the diabetes distress scale (dds-17). the secondary objective is to assess the correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin.

Eligibility criteria:
inclusion criteria: * patients living with type 1 or type 2 diabetes. * patients hospitalised in the diabetes department of the ie3m. * patients aged ⩾ 18 years. * patients agreeing to participate in this study after information. * beneficiary of the health insurance. exclusion criteria: * refusal to participate. * inability to communicate in french. * inability to read or write french. * communication disorders. * history of psychiatric disorders, dementia. * patient under guardianship or curatorship. * patient not affiliated to social security. * patient affiliated to the aide médicale d'etat (ame).

Keywords: diabetes distress
pacap38 induced headache and rosacea-like symptoms in patients with rosacea

Conditions: Rosacea

Summary: the investigators aim is to investigate the incidence of headache and rosacea-like flushing after pituitary adenylate cyclase-activating peptide-38 (pacap38) with and without treatment with sumatriptan in patients with rosacea

pituitary adenylate cyclase-activating peptide-38 (pacap38) plays a role in rosacea pathophysiology. infusions of pacap38 can trigger migraine-like attacks in migraine patients. pacap38 also induces flushing which may imitate rosacea-like flushing. we are investigating whether the flushing after pacap38 resembles rosacea-like flushing, and whether treatment with sumatriptan has an effect on the headache and flushing effects of pacap38. the purpose of this study is to investigate pacap38-induced headache and flushing in patients with rosacea who have been treated with either sumatriptan or placebo using purpose-developed standardized interview. the investigators will use a double-blind, placebo-controlled crossover study design to investigate this.

Eligibility criteria:
inclusion criteria: * diagnosed with rosacea * weight between 50 - 100 kilograms * women in fertile age must not be pregnant and must use adequate contraception exclusion criteria: * migraine more than 5 days per month in average over the past year * any primary headache other than migraine, apart from tension-type headache which must be less than 5 days per month * headache \< 48 hours before experimental day * migraine \< 72 hours before each experimental day * daily / frequent use of any medication apart from contraceptive medication * use of any drug less than 5 times the half-life of the drug at the time of the experiment * women who are pregnant or breast-feeding at the time of the experiment * anamnestic or clinical signs of hypertension (systolic blood pressure \> 150 mmhg and/or diastolic blood pressure \> 100 mmhg) or hypotension (systolic blood pressure \< 90 mmhg and/or diastolic blood pressure \< 50 mmhg) * anamnestic or clinical signs of mental illness, or abuse of alcohol / drugs * patients with glaucoma or prostate hyperplasia * anamnestic or clinical symptoms of any sort that the investigating doctor deemed unfit for participating in the study
transcatheter mitral valvuloplasty pilot study

Conditions: Mitral Valve Insufficiency; Mitral Regurgitation; Mitral Valve Regurgitation

Summary: this study is to evaluate the efficacy and safety of transcatheter mitral valvuloplasty for severe mitral regurgitation


Eligibility criteria:
inclusion criteria: * significant symptomatic mitral regurgitation (mr ≥ 3+) due to primary abnormality of the mitral apparatus \[degenerative mr\] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation. * age 19 and more * written informed consent exclusion criteria: * patients who cannot tolerate procedural anticoagulation or post-procedural antiplatelet regimen * active endocarditis of the mitral valve * rheumatic mitral valve disease * evidence of intracardiac, inferior vena cava (ivc) or femoral venous thrombus

Keywords: mitraclip
123 i-fp-cit spect prescriptions for parkinsonian syndromes

Conditions: Parkinson

Summary: 123i-fp-cit spect (datscan®) allows to detect presynaptic dopamine neuronal denervation. it is recommended to differentiate neurodegenerative parkinsonism from secondary parkinsonian syndromes or from essential tremor, and to distinguish patients with suspected dementia with lewy bodies and those with other subtypes of dementia. the aim of this retrospective study was to evaluate the relevance of 123i-fp-cit spect prescriptions, the profile of prescribers and the evolution of the prescription rate over a ten-year period.

the investigators included 723 patients in this retrospective study between february 2009 and may 2019, in the nuclear medicine department of avicenne university hospital. no patients were excluded. demographic, clinical, brain imaging, and 123i-fp-cit spect data were collected from medical records. the study was conducted in accordance with the declaration of helsinki, and approved by the institutional ethics committee (clea-2019-75). regarding the relevance of the indications, the investigators have defined three groups: " inappropriate ", "uncertain " and " relevant ", also respectively named (a), (b) and (c) groups. in the "inappropriate" group (a), the investigators placed prescriptions with no indication, 123i-fp-cit spect requested to confirm a ps clinically evident, and those prescribed for isolated cognitive-behavioral disturbances with no ps or differential diagnosis mentioned. in the "uncertain" group (b), the investigators did not have sufficient data to determine with certainty whether this was an inappropriate or relevant indication. in the "relevant" group (c), the prescriptions concerned the differential diagnosis between neurodegenerative parkinsonism and secondary parkinsonian syndromes (for instance post-neuroleptics) or other doubtful disorders (alzheimer's disease, essential tremor), clinically uncertain ps (such as an isolated asymmetric resting tremor without akinesia or lead-pipe rigidity) and pd of atypical evolution. data were presented as mean (standard deviation) for numeric variables and as count (percentage) for categorical variables. to compare demographic, clinical and paraclinical data, and the distribution of prescribers between the three groups (i.e. inappropriate (a), uncertain (b) and relevant (c)), one-factor analysis of variance (anova) was used for numerical variables and fisher's exact test for categorical variables. to identify which groups differed from each other, post hoc comparisons were made using the tukey test for numeric variables and the fisher pairwise exact test followed by the benjamini-hochberg correction to account for multiple testing, for categorical variables. for all tests, the significance level was set at p \< 0.05. all data were analyzed using r software (version 3.6.1, r core team).

Eligibility criteria:
inclusion criteria: * parkinsonian patients who benefited from a 123i-fp-cit spect exclusion criteria:
investigating tdcs as a treatment for unipolar and bipolar depression

Conditions: Unipolar Depression; Bipolar Depression

Summary: transcranial direct current stimulation (tdcs) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (rct) and a meta-analysis. this study is a rct of tdcs in depressed patients, testing its efficacy in both unipolar and bipolar depression. mood, cognitive test performance and biomarkers will be measured during the trial.


Eligibility criteria:
inclusion criteria: * 18 years of age or above. * meets criteria for a dsm-iv major depressive episode with duration of at least 4 weeks. * total score ≥ 20 on the montgomery-asberg depression rating scale at study entry. exclusion criteria: * current episode duration greater than 3 years. * failed more than 3 adequate antidepressant trials in current episode. * dsm-iv psychotic disorder. * drug or alcohol abuse or dependence (preceding 3 months). * inadequate response to ect in the current episode of depression. * rapid clinical response required, e.g., high suicide risk. * significant acute suicide risk, defined as follows: suicide attempt within the previous 6 months that required medical treatment; or ≥ 2 suicide attempts in the past 12 months; or has a clear-cut plan for suicide and states that they cannot guarantee that they will call their regular psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study; or in the investigator's opinion, is likely to attempt suicide within the next 6 months. * clinically defined neurological disorder or insult. * metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites. * pregnancy. * concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
subacromial bursa re-implantation after rotator cuff repair

Conditions: Rotator Cuff Injuries

Summary: the purpose of this study is to evaluate clinical outcomes, structural integrity, and tendon organization after rotator cuff repair with and without subacromial bursa implantation and to further co-existing research studies performed at the university of texas health science center of houston (ut health) on ultrashort time to echo-magnetic imaging resonance(ute-mri) techniques and their implication for rotator cuff analysis.


Eligibility criteria:
inclusion criteria: * present with rotator cuff tears requiring arthroscopic repair as confirmed by a medical expert * are able to provide informed consent * can commit to study follow-up visits or procedures exclusion criteria: * are unable to provide informed consent * have additional ipsilateral shoulder complications that will inhibit standard of care treatment and rehabilitation * have active infection at operative site * have active systemic infection * chronic inflammatory condition such as rheumatoid arthritis or lupus * has had a corticosteroid injection to the affected shoulder within the six weeks prior to surgery * have had prior surgical interventions in the past that have modified the existing natural anatomical arrangement of the rotator cuff/shoulder. * non-english speaker

Keywords: subacromial bursa
mat pilates and vascular function in obese females

Conditions: Obese; Elevated Blood Pressure

Summary: obesity is associated with progressive decreases in arterial health and function. it is crucial to prevent or reduce the negative effects of aging on the vasculature by implementing appropriate lifestyle interventions, such as exercise training. we examined the effects of a mat pilates training (mpt) regimen on arterial stiffness (pulse wave velocity, pwv), blood pressure (bp), wave reflection (aix) and endothelial function in obese premenopausal women with elevated bp.

using a parallel experimental design, participants were randomly assigned to either mpt (n=14) or non-exercising control group (n=14) for 12 weeks. participant in the mpt group trained 3 days/week . participants' brachial to ankle pwv (bapwv), systolic and diastolic bp, aix, plasma no levels were measured at baseline and after 20 weeks of their assigned intervention.

Eligibility criteria:
inclusion criteria: * body mass index 30-40 kg/m2 * \<1 h of regular exercise per week in the previous year * systolic/diastolic bp: 120-129mm hg systolic bp and ˂ 80 mm hg for diastolic bp * nonsmokers exclusion criteria: * body mass index ˂30 and ≥40 kg/m2 * chronic diseases * taking oral contraceptives * pregnancy