Kornimate/medical-research-clean huggingface dataset:
analysis of metabolic state in normal-weight and overweight-obese after lifestyle improvement and/or weight loss

Conditions: Overweight and Obesity

Summary: the aim of this study is to design and validate a test, metahealth-test, based in gene expression analysis in blood cells, to quickly and easily analyse metabolic health. this test will be used to analyse metabolic improvement in overweight/obese individuals and in metabolically obese normal-weight (monw) individuals after undergoing a weight loss intervention and/or an intervention for improvement in eating habits and lifestyle.


Eligibility criteria:
inclusion criteria: * age between 18-45 years * participants with no chronic disease (excluding those related to overweight/obesity) exclusion criteria: * minors or older than 45 years * presence of a metabolic illness * intake of regular medication or drugs * precedents of alcohol or drug consumption * physic of psychic disability

Keywords: overweight obesity blood cells metabolic health weight loss
pk study in patients with parkinson's disease with izd174

Conditions: Parkinson Disease

Summary: single center, open-label, intra-individual dose-escalation study in subjects with mild/moderate parkinson's disease

after assessing eligibility during a screening period of up to 4 weeks, up to 6 subjects will be included. subjects will check into the clinic one day prior to dosing (day -1). to evaluate and compare drug exposure levels in plasma and csf, plasma and csf will be serially sampled over a period of 36 hours. subjects will be discharged from the clinic on day 5 after all required study procedures are completed and if medically justified. subjects will return to the clinic approximately 1 week after discharge from the clinic for a follow-up visit.

Eligibility criteria:
inclusion criteria: * the subject is a man or woman aged between 45 and 75, inclusive. * documented clinically established diagnosis of parkinson's disease, hoehn \& yahr stage 1 to 3 and montreal cognitive assessment greater or equal than 26. diagnosis of parkinson's disease consistent wit mds research criteria for the diagnosis of parkinson's disease must include bradykinesia with sequence effect, and motor asymmetry (especially if no rest tremor). diagnosis has to be made less than 3 years prior to screening. * the subject understands the nature and purpose of the study, including possible risks and side effects, and i willing and able to comply with all compulsory stud procedures and provides signed and dated written informed consent (in accordance with local regulations) prior to any study procedures being performed. exclusion criteria: * the subject used any nsaids, steroids, colchicine or anti-il-1 inhibitors within 7 days prior to day 1. * the subject received any investigational drugs within 4 weeks or 5 half-lives (whichever is longer), prior to day 1. * the subject had an active systemic infection (other than common cold) within 2 weeks prior to day 1. * the subject has a history of severe hypersensitivity to previous drugs. * the subject has any severe, progressive or uncontrolled medical condition at screening or on day -1 that in the judgment of the investigator prevents the subject from participating in the study.
treatment of ards with sivelestat sodium

Conditions: Acute Respiratory Distress Syndrome

Summary: neutrophil elastase (ne) released by neutrophils play an important role in inflammatory cascade and lung tissue injury of ards.inhibition of ne is expected to prevent the pathophysiological process of ards and alleviate lung injury. siverestat sodium is a specific inhibitor of ne, which has been proved by basic and observational clinical studies to be effective in alleviating lung injury of ards, but there is a lack of prospective multi-center randomized controlled clinical trials.therefore, this study was intended to evaluate the efficacy of sivelestat sodium in the treatment of ards patients with sirs in a multicenter randomized controlled clinical trial


Eligibility criteria:
inclusion criteria: 1. males and females \> 18 years old and \<75 years old (non-pregnant, non-lactating females). 2. patients fulfilled the berlin diagnostic criteria of acute respiratory distress syndrome, with a arterial oxygen partial pressure (pao2) to fraction of inspired oxygen (fio2) between 150 mmhg and 300 mmhg. 3. signed written informed consent has been obtained exclusion criteria: 1. history of chronic respiratory disease 2. single cardiogenic pulmonary edema 3. apach2 score ≥21 points 4. complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge 5. ards course\>3 days 6. agranulocytosis or receiving immunosuppressive agents or high doses of corticosteroids (methylprednisolone\>40mg/day) 7. pregnancy or breastfeeding 8. participated in this study 9. do not agree to participate in this experiment

Keywords: acute respiratory distress syndrome
cognitive processing therapy (cpt) memory support (ms) study

Conditions: PTSD

Summary: the efficacy of psychological interventions for posttraumatic stress disorder (ptsd) is likely limited by the difficulty participants have learning and remembering important therapy content. accordingly, the present study will examine the utility of integrating a memory support (ms) intervention into cognitive processing therapy (cpt), an empirically supported and widely disseminated treatment for ptsd. ms was designed to integrate techniques aimed at facilitating encoding, consolidation, and retrieval of new learning into existing treatments, and has been shown to improve outcomes when integrated into cognitive therapy for depression. a pilot randomized controlled trial (n=52) comparing cpt with memory support (cpt+ms) to cpt-alone will be conducted. study participants will be adults diagnosed with ptsd. the primary aim of the trial will be to determine if cpt+ms will lead to greater memory and learning of therapy content relative to cpt-alone, and to establish the acceptability and feasibility of integrating ms into cpt. secondary aims include a preliminary examination of treatment efficacy, as indicated by the magnitude of changes in ptsd symptoms between conditions, and target validation, as indicated by associations between memory and learning of therapy content and treatment response. exploratory analyses will examine several indicators of baseline memory-related cognitive functioning as predictors of memory and learning of therapy content, providing preliminary data to inform future research on personalized application of ms. results of the trial will advance scientific knowledge about methods for optimizing memory and learning as a mechanism for improving ptsd treatment outcomes.


Eligibility criteria:
inclusion criteria: * current diagnosis of ptsd as determined by the clinician administered ptsd scale for the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) * for potential participants on psychiatric medication, dose must be stable for the past four weeks. * veteran status exclusion criteria: * current dsm-5 diagnoses of unstable bipolar disorder, past or present psychosis, or organic mental disorder * active suicidal or homicidal ideation with plan or intent * current moderate or severe substance use disorder, as defined by dsm-5 \[i.e., at least 4 diagnostic symptoms of substance use disorder (sud) present\] * prior receipt of cpt or concurrent therapy for ptsd * significant cognitive impairment as indicated by a score \<10th percentile on the montreal cognitive assessment * history of moderate or severe traumatic brain injury (tbi) based on the ohio state university tbi identification method and veterans administration/ department of defense (va/dod) guidelines * high verbal memory ability, as indicated by a score \>1 standard deviation (sd) above the population mean on the california verbal learning test® third edition (cvlt-3) immediate recall task

Keywords: cognitive processing therapy (cpt) memory support (ms) cpt + ms
a single-center study of setmelanotide in patients with prader-willi syndrome

Conditions: Prader-Willi Syndrome; Obesity; Hyperphagia

Summary: this is a phase 2, single-center, open-label study designed to assess the safety and efficacy of setmelanotide in patients with obesity due to prader-willi syndrome (pws) who are 6 to 65 years of age. up to 20 patients are planned to be enrolled. patients will take a daily subcutaneous dose of open-label setmelanotide for up to 26 weeks.


Eligibility criteria:
key inclusion criteria: * confirmed diagnosis of prader-willi syndrome (pws) * age 6 to 65 * bmi ≥30 kg/m2 for patients ≥18 years of age or bmi ≥95th percentile for age and sex * agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after. * patient and/or guardian is able to communicate well with the investigator, understand and comply with the requirements of the study, and understand english and sign the written informed consent. exclusion criteria: * use of weight modulating medications * abnormal hba1c, egfr, alt, ast, bilirubin, t4 values * current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered severe enough to interfere with the trial and/or confound the results. * participation in any clinical trial with an investigational drug/device within 3 months or 5 half-lives, whichever is longer, prior to the first trial dose * hypersensitivity to setmelanotide * diagnosis of severe psychiatric disorders * pregnant and/or breastfeeding other protocol defined inclusion/exclusion criteria may apply.

Keywords: melanocortin 4 receptor (mc4r), mc4r agonist
pulmonary vein (pv) isolation versus box isolation for the treatment of atrial fibrillation

Conditions: Atrial Fibrillation; Radiofrequency Ablation

Summary: curative catheter ablation has been established as an effective therapeutic option for atrial fibrillation (af) that is resistant to pharmacologic rhythm or rate control. however, standard ablative approaches targeting the pulmonary veins (pvs) are associated with a success rate as low as 40%. in a recent study, kumagai et al. described a new approach of catheter ablation of af isolating the posterior left atrium including all pvs (called box isolation). in kumagai's study, 46 patients with symptomatic af underwent box isolation. at 6 months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs, with a single procedure success rate of 87% (40/46). this study provided new evidence supporting the hypothesis that the posterior wall is of high importance for the maintenance of af. the aim of the investigators study is to determine the efficacy of two different approaches of catheter ablation (standard pv isolation vs. box isolation) for the treatment of chronic af.


Eligibility criteria:
inclusion criteria: * patients undergoing clinically indicated pulmonary vein ablation for atrial fibrillation. exclusion criteria: * unable to understand consent form. not scheduled for clinically indicated pulmonary vein ablation
tiva vs inhalational mode of anaesthesia

Conditions: Anesthesia Awareness

Summary: sevoflurane based inhalational anaesthesia is the preferred mode of anesthesia for small duration cases. but in recent times, concept of rapid discharge, day care procedures, and green environment has created the need of new modalities of anaesthesia for such cases. considering such factor, investigators have planned using tiva i.e. total intravenous anaesthesia with inj. propofol and inj. dexmedetomidine infusions for maintenance of anesthesia in modified radical mastectomy (mrm). by comparing the two modalities of anaesthesia i.e. tiva vs inhalational investigators are trying to find out whether tiva is feasible, cost effective and comparable to inhalational anaesthesia in terms of intraoperative hemodynamic stability, pain, intraoperative awareness and recovery profile. this comparison and analysis will help to determine if tiva can be used as the sole mode of anaesthesia during mrm as it will initiate early discharge of patient and will contribute to the green ot concept.

aim: to compare tiva vs inhalational mode of anaesthesia in patients undergoing modified radical mastectomy objective: * feasibility of tiva in modified radical mastectomy * cost - effectiveness of tiva vs inhalational anesthesia * effectiveness of tiva as compared to inhalational anaesthesia by comparing intraoperative hemodynamic parameters and recovery profile. study design: it will be a prospective randomized controlled interventional type of study. sample size: total 100 patients will be recruited for two groups i.e. 50 each in -tiva (t) and inhalational (i) group. groups will be allocated as per chit system to remove the bias. in group t: (tiva): inj. dexmedetomidine will be started at induction @1mcg/kg over 10 min followed by 0.2 to 0.7 mcg/kg/hr along with propofol @ 75mcg/kg/min (25-100 mcg/kg/min) for maintenance of anaesthesia. in group i: (inhalational): both nitrous oxide (in ratio of 50:50 with oxygen) and sevoflurane will be started at induction. in both groups drugs and gases (respective to groups) will be titrated to maintain a bispectral index value between 40-60. anaesthetic drugs will be stopped at last skin suture. soon after reversal- recovery profile, modified aldrete score will be recorded along with time taken to first eye opening and attainment of bis value of \>90. at the end of case amount of each agents consumed will be recorded - i.e. nitrous oxide, sevoflurane, propofol, dexmedetomodine- for cost analysis.

Eligibility criteria:
inclusion criteria: * age group: 30-65 yrs * asa status: 1-3 * use of endotracheal tube for securing the airway exclusion criteria: * ckd, cld patients * cardiac dysfunction * psychotic and neurotic disorders * drug addiction * bmi \> 30 * use of supraglottic device * use of any nerve blocks

Keywords: total intravenous anesthesia
original methodology for assessing the impact of the coronavirus health crisis on psychotropic drug use

Conditions: Psychotropic Drugs

Summary: the health crisis linked to the coronavirus has had a significant impact on the mental health. the question of the repercussion of this crisis on the consumption of psychotropic drugs is crucial. it is all the more true in france, which was already among the countries with the highest consumption of psychotropic drugs before the crisis. indeed, an increase in the number of reimbursements for anxiolytic, hypnotic and antidepressant drugs has been highlighted in the context of the health crisis, using data from the health insurance database. to enhance the understanding about the impacts of the health crisis on the use of psychotropic drugs, it is essential to characterize the evolution of the use at the individual level. the main objective is to assess the impact of the coronavirus-related health crisis on the consumption of psychotropic drugs by studying the trajectories of reimbursements. the secondary objective of the project is to evaluate the evolution of problematic consumption of psychotropic drugs in the context of the health crisis.

the project will allow studying the evolution of the use of psychotropics since the coronavirus-related health crisis according to the temporality of consumption (succession and/or concomitance of consumption) or their persistence over time. this project has two major aims: * pharmacosurveillance: evaluation of the impact of psychotropic drug consumption in the context of the health crisis related to the coronavirus. the consumption of psychotropic drugs is a public health issue in france and concerns the entire general population. even before the crisis, france was one of the countries in the world where the consumption of psychotropic drugs was the highest. * scientific: use of an innovative methodology for assessing the impact of pharmaco-epidemiology (trajectories based on reimbursement data).

Eligibility criteria:
inclusion criteria: * subjects identified in the french national healthcare data system (snds) in 2018, 2019, 2020 and 2021 at national level, alive on 01/01/2018, age ≥ 16 years on 01/01/2020. exclusion criteria: * institutionalization at least one day in a residential facility for dependent elderly people with an internal pharmacy in 2018, 2019, 2020 or 2021.

Keywords: psychotropic drugs, sars-cov-2, health impact assessment
noice vs. nothing | thermode

Conditions: Pain; Anxiety

Summary: this is a prospective, randomized, crossover study on healthy volunteers evaluating the impact of spatial audio on heat pain threshold (hpt). the primary center for this study will be lucile packard children's hospital (stanford university, palo alto, ca) and other stanford affiliated sites.

virtual reality (vr) is a developing, non-pharmaceutical tool that has been shown to reduce perceived anxiety and pain among patients. although the use of vr in clinical settings is becoming more prevalent, the technology's application has been limited by variable factors, one being patient reluctance in using the vr headset itself. for patients who are provided the opportunity to utilize vr, there are a subset of patients who find discomfort in utilizing vr, as the visual screen of the vr headset can obstruct the patient's view of their surroundings while undergoing a procedure. while spatial audio applications have been found to be an effective intervention for reducing stress and negative moods and evoking positive emotions for patients, it is unknown to what extent spatial audio can reduce pain perceptions. this study aims to investigate the effects of spatial audio on heat pain threshold in clinical settings, using the novel noice device. unlike traditional vr, noice is an immersive headset that provides only spatial audio elements, which can be modulated using a variety of hand gestures. this device will serve as an alternate form of distraction for participants who prefer to not have their vision obscured when undergoing a procedure. the objective of this proposal is to evaluate the impact of spatial audio on heat pain threshold (hpt) and heat pain sensitivity (hps), while also analyzing ergonomics, system usability, and device satisfaction of the noice device.

Eligibility criteria:
inclusion criteria: * ages 18 years and older * english-speaking * intact hearing exclusion criteria: * use chronotropic heart medications * use pain medications * current hearing loss

Keywords: thermal sensory analyzer (tsa-ii) peltier-based contact thermode noice device
effect of exercise in pediatric hemophilia

Conditions: Hemophilia A, Severe; Hemophilia Arthropathy

Summary: this study investigates the effect of exercise training on pain, physical activity and quality of life in pediatric hemophilia patients.

hemophilia is a congenital x-linked recessive disease characterized by the lack or absence of clotting factors in the blood. male individuals with problems in the x chromosome are affected, females are carriers. there are two common types, factor viii (hemophilia a) and factor ix (hemophilia b), and the percentage of the exposed factor in circulation determines the degree of hemophilia disease (\ 20% mild). the most common clinical symptoms in hemophilia are intra-articular and intramuscular spontaneous bleeding, a history of bleeding that lasts longer than expected after trauma, hemarthrosis and hematomas after crawling or walking in children with moderate or severe hemophilia. pain, swelling, redness, temperature increase and limitation of movement occur in the bleeding joint. bleeding into the joint space causes inflammation in the synovial membrane and synovitis occurs. with chronic synovitis, the synovial membrane thickens. degeneration of the joint cartilage and narrowing of the joint space occurs. hemarthroses constitute 70-80% of bleeding findings. the most common bleeding joints are knee joints with a rate of 45%. besides pharmacological treatment for joint and muscle bleeding, the most suitable option is exercise therapy. the aim of our study is to examine the effect of exercise agitation on pain, physical activity and quality of life in pediatric hemophilia patients. the results of the study indicate that the exercise protocol developed for the lower extremity in pediatric hemophilia patients will have a positive effect on pain, physical activity and quality of life.

Eligibility criteria:
inclusion criteria: * diagnosed with hemophilia (hemophilia a) by a hematologist * hemophilia is moderate or severe, without spontaneous bleeding complaints * having a history of bleeding in the knee joint * not doing any regular exercise * willing to continue working and will not start other treatment during the study * patients whose parents were informed about the study and whose consent form was obtained exclusion criteria: * those who have undergone another surgery (joint debridement, fracture, knee replacement) that will affect lower extremity function * those with neurological disease or any sensory loss or peripheral nerve injury that may affect functional performance and balance

Keywords: hemophilia factor viii closed chain exercise knee
study of oral upadacitinib to assess change in disease activity and adverse events in adult participants with ulcerative colitis or crohn's disease

Conditions: Ulcerative Colitis; Crohn's Disease

Summary: ulcerative colitis (uc) is an idiopathic, chronic, inflammatory disease affecting the colon. crohn's disease (cd) is an incurable chronic inflammatory disorder of the gastrointestinal tract. this study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis and crohn's disease. adverse events and change in disease activity will be assessed. upadacitinib is an approved drug for treating atopic dermatitis (ad), psoriatic arthritis (psa), ankylosing spondylitis (as), non-radiographic axial spondyloarthritis (nr-axspa), ulcerative colitis (uc), and crohn's disease (cd). approximately 600 adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in korea. upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. participants in the study will be followed for up to 52 weeks. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * participants diagnosis with ulcerative colitis or crohn's disease suitable for the treatment with upadacitinib. * participants prescribed upadacitinib in accordance with the approved local label. exclusion criteria: * participants with any contraindication to upadacitinib. * participants currently participating in another clinical research not including observational study.

Keywords: inflammatory bowel diseases upadacitinib rinvoq ulcerative colitis crohn's disease