Kornimate/medical-research-clean huggingface dataset:
initial validation of promis physical function/disability scales in rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: the patient-reported outcomes measurement information system (promis) is an nih roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. in the first four years of its existence, the promis network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. during the item banking process, the promis network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. the item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (irt). using these irt calibrations, computerized adaptive test (cat) algorithms were developed and implemented. the network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as cats, and validate the item banks. more information on the promis network can be found at www.nihpromis.org.

this is a longitudinal clinical validation study of the promis physical function, fatigue, and pain impact short forms in patients with rheumatoid arthritis (ra). patients will complete assessments at two points: baseline and 6 months post-baseline. the responsiveness of six promis static forms (physical function \[haq, pf-10, 10 and 20 item short forms\], fatigue, and pain impact) will be evaluated for change over the 6-month period. physical function change scores will be contrasted with established legacy physical function instruments. the test of "responsiveness" is defined as the ability of the instrument to detect change after major treatment intensification, self-reported improvement in functioning, or positive changes in patient global scores. the order of presentation of forms will be randomly assigned to eliminate questionnaire fatigue or other order effects as factors. we will also evaluate the test-retest reliability of four promis static forms (haq and pf-10 physical function, fatigue, and pain impact) in a random subsample of patients at 1-week post-baseline. in addition, we will evaluate convergent validity of promis measures of physical function by comparing self-report with observation of performance of physical function tasks in a subsample of patients randomly selected from the local geographic region.

Eligibility criteria:
inclusion criteria: * rheumatologist-diagnosed ra * meets one of the conditions for treatment intensification as described in the protocol * ability to read, write, and speak english * ability to understand and provide informed consent exclusion criteria: * unable or unwilling to complete questionnaires
the role of gut leakage markers and microbiota signature in coronary artery disease.

Conditions: Coronary Artery Disease; Intestinal Disease

Summary: define a signature of gut microbiota composition and related metabolites in patients with st-elevation myocardial infarction, non st-elevation myocardial infarction and chronic coronary disease (cad).

a total of 200 patients, allocated to 50 patients with chronic coronary syndrome, 75 patients with non-st elevation myocardial infarction and 75 patients with st- elevation myocardial infarction will be included. clinical information, blood samples and fecal samples will be collected. fecal and blood samples will be collected once in patients with chronic disease and in patients with acute coronary syndrome; in the acute phase and after 3 months.

Eligibility criteria:
inclusion criteria: * coronary heart disease verified by coronary angiography exclusion criteria: * current infection requiring intravenous antibiotics * inflammatory bowel disease * renal failure with creatinine \> 200µmol/l * hepatic impairment * pregnancy * previous bariatric surgery * colostomy * active malignant disease

Keywords: gut leakage microbiota coronary artery disease stemi nstemi chronic coronary syndrome
safety and efficacy study of ai wall thickness measurement (echonet-lvh-rct)

Conditions: Heart Failure

Summary: to determine whether an integrated ai decision support can save time and improve accuracy of assessment of echocardiograms, the investigators are conducting a blinded, randomized controlled study of ai guided measurements of wall thickness in parasternal long axis view compared to sonographer measurements in preliminary readings of echocardiograms.


Eligibility criteria:
inclusion criteria: * sonographers and cardiologists at csmc echocardiography lab * all transthoracic echocardiogram studies performed in the csmc echocardiogram lab exclusion criteria: * transthoracic echocardiogram studies not able to be measured by sonographers in run in period
clinical trial to evaluate the efficacy and the tolerance of an omega 3 fatty acids supplementation in adhd children

Conditions: Attention Deficit Hyperactivity Disorder

Summary: principal focus is to evaluate the effects of omega 3 fatty acids supplementation on the adhd children's behaviour during 12 weeks on two years. the secondary focus is to evaluate the effects of omega 3 fatty acids supplementation on the lexical level,intentional abilities, anxiety and depression. the omega 3 fatty acids don't present adverse side effects. the inclusion to the trial could avoid the intake the methylphenidate and its associated adverse side effects.


Eligibility criteria:
inclusion criteria: * 6 to 15 years and 11 months of age adhd children with hyperactivity confirmed dy dsm iv criteria children and parents' consent exclusion criteria: * without methylphenidate treatment fish or other sea products allergic intake of sea omega 3 fatty acids supplments more one week during 3 months before the trial children need quickly to take methylphenidate: social, family, or school risk intake methylphenidate 30 days before the trial or/and intake it during one consecutive week

Keywords: 160 children parallel group
targeted decision making in renal cell carcinoma relying on a radiogenomics translational platform

Conditions: Renal Tumors

Summary: this project aims to provide an accurate strategy to guide the decision making relying on tumor biopsies using standard histology, immunohistochemistry (ihc), spatial transcriptomics, genomics combined with magnetic resonance imaging (mri) and radiomics. moreover, the investigators will explore potential markers indicative of response to systemic agents or ablative therapy.


Eligibility criteria:
inclusion criteria: * presence of a renal mass up to 4 cm * adult \> 18 years * candidate to renal surgery * informed consent signed exclusion criteria: * contraindication for mri
pharmacogenetics of b2-agonists in asthma.

Conditions: Asthma

Summary: this study will help to find out if having a certain genetic makeup influences how a person with asthma responds to salmeterol, one of the two drugs in advair(r).

patients are being asked to take part in this research study because they have asthma. this clinical research study is being done to see if an asthmatic's gene make-up (dna is made up of genes) affects the way they respond to a particular asthma medication called salmeterol. certain genes make people tall or short. certain genes give people brown or black hair. similarly, certain genes may be associated with the way patients respond to asthma medications. salmeterol xinafoate (a long acting bronchodilator) and fluticasone propionate (an inhaled corticosteroid) are the medicines contained in advair diskus. during this study, patients with asthma will receive fluticasone inhaler (called flovent) and advair diskus. the investigators want to find out if patients with asthma with certain genes respond in different ways to the salmeterol in advair diskus. the investigators also want to find out if patients with asthma with certain genes who are treated with salmeterol for two weeks have their airways open up less than usual when they use albuterol.

Eligibility criteria:
inclusion criteria: * diplotype: whites with specific diplotype and african americans with specific diplotypes. * gender: male or female. women are eligible if they are not pregnant or lactating. females subjects of childbearing potential will undergo a urine pregnancy test prior to each methacholine challenge test. * age: 10 years and older. * asthma diagnosis: physician diagnosed asthma according to american thoracic society criteria for at least 3 months. * asthma therapy: there is no requirement for previous asthma therapy to be included in this study. * asthma severity: forced expiratory volume in the first second (fev1) must be \>= 60% of predicted normal values for age, height, and gender. * methacholine challenge test provocative concentration (20% fall in fev1) of \<=12\]mg/ml. exclusion criteria: * history of life-threatening asthma: any episode of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures. * asthma instability: hospitalization for asthma within 3 months of visit 1. * concurrent respiratory disease: any respiratory disease other than asthma. * sensitivities: sensitivities to methacholine, flovent® mdi, ipratropium bromide, albuterol, or advair diskus® that would put the safety of the subject at risk. * respiratory tract infection: any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks immediately preceding visit 1, or for which antibiotic therapy has not been completed at least 2 weeks prior to visit 1. * expected exposure to pollen allergen to which the patient is sensitive (by medical history of symptoms) during the 29 day study period. these patients can be studied when pollen exposure to which they are sensitive will not occur.

Keywords: asthma pharmacogenetics salmeterol african american white
risk factors and application of risk management strategies in hemodialysis patients complicated with heart failure

Conditions: Hemodialysis; Heart Failure

Summary: age, hyperglycemia, inflammation, and comorbidities (hypertension, diabetes, coronary disease) independently increase hf risk in hemodialysis patients. targeted risk management reduces psychological distress, complications, and enhances care outcomes.

to identify risk factors for heart failure (hf) in hemodialysis patients and assess the efficacy of targeted risk management strategies in improving prognosis and care quality. a total of 170 hospitalized dialysis patients from january 2022 to january 2024 were enrolled. they were divided into two groups based on the presence or absence of heart failure: the heart failure group (n=80) and the non-heart failure group (n=90). the inducing factors were analyzed, and targeted risk management strategies were implemented, with the participants further divided into a conventional group (n=40) and a study group (n=40) to explore the effect of these strategies.

Eligibility criteria:
inclusion criteria: * patients were aged 18 years or older who had been undergoing regular hemodialysis treatment for more than three months. * patients were in good cardiopulmonary health without severe acute or chronic diseases, and were capable of undergoing the study-related examinations and treatments. * patients had not undergone major surgeries or experienced acute complications within the three months prior to enrollment, and their conditions were stable. * patients demonstrated high compliance by following medical advice and regularly attending dialysis sessions and related examinations. ⑤patients were able to understand the study objectives, had signed the informed consent form, and were willing to cooperate with follow-up visits and long-term observation. exclusion criteria: * patients were excluded if they had severe liver diseases (e.g., cirrhosis or liver failure), significant systemic infections, active tuberculosis, malignant tumors, connective tissue diseases, or other major illnesses. * patients with congenital kidney diseases, congenital heart defects, or other severe congenital structural abnormalities were excluded. * patients who had a documented history of severe cardiac diseases were excluded, including those with primary/secondary cardiomyopathy, valvular heart disease, myocarditis, or pericardial diseases. * patients were excluded if they had severe mental disorders or cognitive impairments that prevented their cooperation with study assessments or treatments. ⑤patients whose clinical records or examination data were incomplete, thereby precluding effective analysis, were excluded.
a clinical trial comparing the efficacy and safety of exubera® and lantus®

Conditions: Diabetes Mellitus, Type 2

Summary: to compare efficacy and safety of exubera® vs lantus® in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * diabetes mellitus, type 2 on oral agents * age \> 30 years exclusion criteria: * severe asthma, severe chronic obstructive pulmonary disease * smoking

Keywords: type 2 diabetes, insulin, glycemic control
vl-2397 compared to standard first-line treatment for invasive aspergillosis (ia) in adults

Conditions: Invasive Aspergillosis; Invasive Pulmonary Aspergillosis

Summary: the purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a novel mechanism of action in immunocompromised adults with invasive aspergillosis.

to compare the safety and efficacy of vl-2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant (allo-hct).

Eligibility criteria:
inclusion criteria: * acute leukemia (aml or all) patient or allo-hct recipient with a diagnosis of ia exclusion criteria: * pregnant or breastfeeding * ia involving sites other than lungs and sinuses * graft failure, acute or extensive chronic gvhd * uncontrolled diabetes

Keywords: ia
nutrition, overgrowth, and vaccine efficacy in low-income settings

Conditions: Small Intestine Bacterial Overgrowth

Summary: the purpose of this study is to assess the impact of small intestine bacterial overgrowth (sibo) on childhood nutritional status, growth, and oral vaccine efficacy.


Eligibility criteria:
inclusion criteria: * child previously enrolled in the field studies protocol (enrollments in both studies may occur simultaneously) * mother willing to sign informed consent form. * healthy infant aged less than 7 days old exclusion criteria: * parents are not willing to have child's blood drawn, oral fluid collected, urine collected, or breath testing performed. * history of seizures, other apparent neurologic disorders, or other congenital abnormalities involving major organ systems.

Keywords: oral vaccination nutrition
analgesic effects of topical ketamine mouthwash in patients receiving chemoradiation or radiotherapy for head & neck cancer

Conditions: Mucositis; Head and Neck Cancer

Summary: * the primary objective is to determine the reduction in pain score by ketamine mouthwash compared to placebo in head and neck cancer patients with refractory mucositis. * the secondary objectives are to describe the duration of analgesia and adverse effects associated with ketamine and placebo.

we would like to determine the effectiveness of ketamine mouthwash in providing pain relief to subjects with head and neck cancer suffering from mucositis, a common adverse event of radiation therapy and chemoradiation therapy. ketamine is a schedule iii controlled substance that is generally used to provide anesthesia for short diagnostic and surgical procedures. ten subjects will be randomized to two treatment arms. group a will receive ketamine on monday, placebo on wednesday, and ketamine on friday. group b will receive placebo on monday, ketamine on wednesday, and placebo on friday. each subject will swish the study drug or placebo for 2 minutes and spit it out. the use of non-maintenance mucositis medications such as dlm solution will not be allowed during the clinic visit. subjects may resume non-maintenance mucositis medications at home. subjects will be asked to document adverse effects and pain scores at 30, 45, and 60 minutes after study medication. the richmond agitation and sedation scale (rass) will be used to determine a subject's sedation level, if necessary. treatment will last for up to 6 weeks unless an illness or an event occurs that prevents continuation, intolerance to the agent, adverse events, resolution of mucositis pain, or the decision to withdraw from the study.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with head and neck tumors (any histology) receiving ongoing chemoradiation or radiation therapy * subjects with mucositis pain refractory to topical management, defined as any self-reported pain score of \> 2 in the 24 hours prior to enrollment despite use of topical agents as prescribed * age ≥ 18 years * ability to understand and willingness to consent and to sign consent form exclusion criteria: * active substance abuse at time of registration (alcohol, drugs, non-prescription use of controlled substances) * subjects with history of allergic reactions to ketamine * persistent oral bleeding: \> 15 ml (estimated) per day * pregnancy or breast feeding

Keywords: mucositis head and neck cancer radiation therapy chemoradiation oral pain
cervical spinal cord stimulation in cerebral vasospasm

Conditions: Cerebral Vasospasm

Summary: the study is a non-blinded evaluation of the use of cervical spinal cord stimulation (scs) for treatment of patients with hunt and hess grade 1-2 subarachnoid hemorrhage and evidence of cerebral vasospasm.

the study is a non-blinded evaluation of the use of cervical spinal cord stimulation (scs) for treatment of patients with hunt and hess grade 1-2 subarachnoid hemorrhage and evidence of cerebral vasospasm. stimulation will be provided with electrodes placed percutaneously in the upper cervical epidural space. the outcome of 5 patients will be studied with focus on possible adverse events related to the intervention. vasospasm response to treatment will be measured as a secondary outcome. middle cerebral artery flow velocity will be followed by transcranial doppler and clinical outcome measured by nih stroke scale. flow velocities will be monitored daily by transcranial doppler and nih stroke scale performed daily for 7 days, after which spinal cord stimulation will be discontinued and the epidural lead removed.

Eligibility criteria:
inclusion criteria: * a history of aneurysmal subarachnoid hemorrhage and will have aneurysm secured by clipping or coiling. * evidence of vasospasm on tcd with mca mean flow velocity \>120 cm/s. * patients must be clinically stable to leave the icu for the study intervention. * patients will have hunt and hess grade 1-2 non-traumatic subarachnoid hemorrhage. * patient should be oriented patients able to provide informed consent. exclusion criteria: * patients with non-aneurysmal hemorrhage * patient with coagulopathy (ptt\>40, or inr \> 1.2) * thrombocytopenia (platelets \<100 x 103 per mm2). * use of anticoagulation or antiplatelet medication within the known clinical effective period of the particular medication. * allergy to nimodipine. * history of cervical or thoracic spine surgery. * skin infection at site of catheter placement. * sepsis. pregnancy. age less than 18 or greater than 80. active diagnosis of cancer or history of metastatic cancer. presence of cardiac defibrillator. inability or unwillingness of patient to give informed consent. patients found to be clinically neurologically unstable, hemodynamically unstable, or suffering from unstable intracranial pressure at the time of assessment for lead placement will not have the intervention.
comparison of the effect of eprosartan and eprosartan mesylate on blood pressure in essential hypertension

Conditions: Essential Hypertension

Summary: aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. the new formulation is compared to the currently marketed eprosartan tablet. equivalent efficacy in blood pressure lowering effects should be demonstrated.


Eligibility criteria:
inclusion criteria * males or females with essential hypertension, blood pressure values between 140 mmhg and 179 mmhg systolic and between 90 mmhg and 109 mmhg diastolic * given written informed consent prior to starting the study exclusion criteria * women with childbearing potential, breast feeding or pregnant; * inability to discontinue all prior antihypertensive medication; * secondary hypertension * severe hypertension * severe diabetes mellitus (hba1c greater 8.5%)
benefit of the use of 3d models and tools in hepatectomy planning for hepatocarcinomas

Conditions: Hepatocarcinoma

Summary: the aim of this study is to assess the benefit of 3d models in the planning of hepatic resection by comparing the changes in the surgical plan based on the analysis of conventional preoperative images (ct-scan and mri), compared to the surgical plan based on the analysis of 3d reconstruction.

the detailed anatomical description of the liver described by couinaud in 1954 is the basis for hepatic surgery. surgical resection is the approach leading to the best survival rate in case of liver cancer. in hepatocarcinomas, systematic removal of the infected liver segment is considered the most effective technique to eliminate tumour, potential satellite nodules and avoid vascular spread. resectability rate highly depends on the analysis of preoperative images. however, in 20% of cases, there are modifications compared with the initial surgical plan leading to an increase in morbidity rate. in 2002, couinaud highlighted the difficulty of identifying portal pedicles, especially because of anatomical variations, and recommended the use of a three-dimensional reconstruction from images provided by a helical scanner. the hypothesis of the study is that 3d models would improve surgical planning leading to a decrease in intra-operative adjustments and mortality. the aim of this multicentric, prospective study is to assess the benefit of 3d models in the surgical management of hepatocarcinomas, more specifically in the detailed analysis of 3d vascular structures and in the surgery planning with resection merges evaluation. the validation of this virtual method will be built on the comparison of the surgical plan based on the analysis of conventional preoperative images (ct-scan and mri) and the surgical plan based on the analysis of 3d reconstruction.

Eligibility criteria:
inclusion criteria: * patient with a hepatocarcinoma, eligible for surgical resection * patient over 18 years old * patient able to understand the study and provide written informed consent * patient affiliated to the french social security system. exclusion criteria: * patient with other liver tumours * patient whose general condition is not suitable for study participation (who ≥ 3) * patient with a condition preventing its participation to study procedures, according to investigator's judgment * patient with contraindications to injected ct-scan or mri: allergic reaction to contrast agents, kidney failure, pacemaker, claustrophobia * pregnancy or breastfeeding * patient in exclusion period (determined by a previous study or in progress) * patient in custody * patient under guardianship.

Keywords: surgical planning ct-scan mri 3d model hepatocarcinoma eligible for surgical resection