Kornimate/medical-research-clean huggingface dataset:
artemis-ph - study of ambrisentan in subjects with pulmonary hypertension associated with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis; Pulmonary Hypertension

Summary: ambrisentan is an endothelin receptor antagonist used for the treatment of pulmonary hypertension (ph). based on research suggesting a role for endothelin-1 in the pathogenesis of idiopathic pulmonary fibrosis (ipf) and the poor prognosis for patients with ipf who are also diagnosed with ph, this study was designed to evaluate the effectiveness and safety of ambrisentan in that patient population.


Eligibility criteria:
selected inclusion criteria: * weight ≥ 40 kg at screening * diagnosis of ipf based on modified american thoracic society-european respiratory society guidelines * diagnosis of ph based on the following hemodynamic requirements: mean pulmonary artery pressure (mpap ≥ 25 mm hg; pulmonary vascular resistance \> 240 dyne.sec/cm\^5; pulmonary capillary wedge pressure or left ventricular end-diastolic pressure ≤ 15 mm hg * forced vital capacity (fvc) ≥ 40% * able to walk at least 50 meters during two 6-minute walk tests * if receiving calcium channel blockers, low-dose oral corticosteroids, immunosuppressive, cytoxic, or antifibrotic drugs dose must have been stable. selected exclusion criteria: * diagnosis of ph primarily due to an etiology other than ipf * surgical lung biopsy diagnosis other than usual interstitial pneumonia * other known cause of interstitial lung disease * evidence of significant obstructive lung disease * recent hospitalization for an acute exacerbation of ipf * recent active pulmonary or upper respiratory tract infection * left ventricular ejection fraction \< 40% * serum creatinine ≥ 2.5 mg/dl * required hemodialysis, peritoneal dialysis, or hemofiltration * female subject who was pregnant or breastfeeding * recent treatment for ph with an endothelin receptor antagonist (era), phosphodiesterase type 5 inhibitor, or prostacyclin derivative * recent treatment with high dose oral corticosteroids * recent treatment (within 4 weeks prior to screening) with imatinib mesylate (gleevec) * alanine aminotransferase or aspartate aminotransferase lab value that was greater than 1.5 x the upper limit of the normal range * discontinued other era treatment for any adverse reaction other than those associated with liver function test abnormalities

Keywords: idiopathic pulmonary fibrosis pulmonary hypertension ph ipf ambrisentan era endothelin receptor antagonist cardiovascular
predictors of sorafenib response in hcc

Conditions: Hepatocellular Carcinoma

Summary: evaluating the nutrition status of patients with advanced hcc who received sorafenib. using the pretreatment nutrition status and quality of life as predictors to sorafenib response

this a cross sectional study will be conducted on 100 hcc treated with sorafenib data were gathered from medical records, including age sex body weight and height (bmi) pre-therapy laboratory counts of white cells, neutrophils, lymphocytes, monocyte, hemoglobin and platelets; bilirubin, albumin and globulin concentration, ast, alt, afp, pt and conc barcelona clinic liver cancer stage (bclc) of all patients the neutrophil-to- lymphocyte ratio (nlr) was calculated by dividing the neutrophil count by the lymphocyte count. the platelet- to-lymphocyte ratio (plr) was calculated by dividing the platelet count by the lymphocyte count. weight loss difference after treatment portal hypertension was defined as presence of either collaterals on radiological examination, esophageal varices by upper gastrointestinal endoscopy and/or thrombocytopenia. quality of life assessment. qol was assessed using fact hepatobiliary symptom index (fhsi-8) questionnaire. qol was assessed at base line and 3-6 months after start of treatment.

Eligibility criteria:
inclusion criteria: * hcc recieved sorafenib exclusion criteria: * patient refuse to participate * patients recieving other treatment modalities

Keywords: nutrition assessment hcc sorafenib
effect of home health case management on asthma morbidity

Conditions: Asthma; Childhood Asthma

Summary: the objective of our program is to evaluate the effect of home health nurse intervention and education on hospital admissions, er utilization and asthma control of passport asthma patients. the investigators hypothesize that case management and in home education by nurses will decrease hospitalizations and er asthma visits and improves disease control in our population. our clinic population consists of primarily inner-city, low income, medicaid recipients. this population suffers from severe asthma much more than the typical pediatric population. asthma remains the most frequent cause of hospital admission for our patient population. home health nurse asthma education and home visits have been reported to reduce asthma triggers in the home and improve asthma control. the unique partnership between the pediatrician and the home health nurse will give us a better understanding of the health needs for this population, will improve quality of care and deliver more cost effective care.

asthma patients age 3-17 enrolled in our clinic who have been seen in the er, hospital or clinic for an asthma exacerbation will be invited to participate. once enrolled they will have a home health nurse visit their home and provide medical assessment, asthma education and determine if the patients has all needed medications available. they enrolled patient will receive another home visit at 1, 4, and 12 months after enrollment. the medical record will be reviewed and er visits and hospitalizations recorded.

Eligibility criteria:
inclusion criteria: * children age 3-17 years with asthma who attend our clinic who present with an asthma exacerbation to the clinic, er or hospital. exclusion criteria: * patients with airway anomalies or tracheostomy

Keywords: asthma home health nursing patient education
cellular and molecular biomarkers in patients with lichen planus

Conditions: Lichen Planus

Summary: lichen planus (lp) is a chronic inflammatory disease of unknown aetiology, affecting the skin and mucous membranes, characterised by a cd8+ cytotoxic t-cell infiltrate, associated with epithelial cell death and disruption of the basement membrane zone. in previous work, t cell antigen receptor (tcr) repertoire studies were performed. in all patients tested, whether with erosive or non-erosive lp, unique nucleotide sequences, called clonotypes, have been identified. they appear during the process of tcr gene rearrangement. these clonotypes are specific for human papillomavirus (hpv) in blood and lesions, suggesting antigenic stimulation of these clonotypes by a viral epitope of hpv, which crosses with an epitope on keratinocytes. the diagnosis of lp is made on the basis of clinical and histological criteria, but in some patients and in some anatomical locations, the diagnosis is difficult to make and lp may be confused with other skin conditions.

lichen planus (lp) is a chronic inflammatory disease of unknown aetiology, affecting the skin and mucous membranes, characterised by a cd8+ cytotoxic t-cell infiltrate, associated with epithelial cell death and disruption of the basement membrane zone. several triggers have been proposed for lp, including viral antigens. in previous work, t cell antigen receptor (tcr) repertoire studies were performed, i.e. investigating the diversity of tcrs expressed on the surface of an individual's lymphocyte population. in all patients tested, whether with erosive or non-erosive lp, unique nucleotide sequences, called clonotypes, have been identified. they appear during the process of tcr gene rearrangement. these clonotypes are specific for human papillomavirus (hpv) in blood and lesions, suggesting antigenic stimulation of these clonotypes by a viral epitope of hpv, which crosses with an epitope on keratinocytes. the diagnosis of lp is made on the basis of clinical and histological criteria, but in some patients and in some anatomical locations, the diagnosis is difficult to make and lp may be confused with other skin conditions.

Eligibility criteria:
inclusion criteria: * subject coming at the time of diagnosis of the disease before any systemic treatment, or at the time of a progressive episode of the disease, without systemic treatment or after cessation of immunomodulatory or immunosuppressive treatment * ability to give their consent in writing * must understand spoken and written french * affiliated to the french social security or assimilated regimes exclusion criteria: * dermatosis exclusively localised in the skin folds or on the face (risk of scarring from biopsies)
sarcopenia, obesity, and resistance training

Conditions: Sarcopenia; Aging; Obesity

Summary: the purpose of this study was to examine the effects of resistance training on sarcopenic obesity in older women.

to examine the effects of resistance training on sarcopenic obesity in older women, a representative sample of older women from brasília, brazil (n\>244 subjects), will be recruited and invited to undergo body composition measurement using dual-energy x-ray absorptiometry. moreover, the sarcopenic obesity index and isokinetic strength evaluations will be performed. it will be a single-blind randomized, controlled 24-week clinical trial, in which experimental group will receive a progressive resistance training program, meanwhile control group will receive instructions to maintain their lifestyle habits. randomization will be conducted by computer-generated list in blocks of 10. additionally, body composition, strength assessment, and sarcopenic index will collected and compared after the intervention period.

Eligibility criteria:
inclusion criteria: * community older women (aged between 60 and 80 years). exclusion criteria: * individuals with any metallic implant or artificial pacemaker, who had undergone hip surgery, who were unable to walk without assistance and those affected by metabolic or endocrine disorders that affect the muscular system.
a study of adolescents undergoing a mindfulness training during covid-19

Conditions: Healthy

Summary: the covid-19 pandemic has been significantly affecting people's lives around the globe. social distancing, self-quarantine, shelter-in-place measures, economic challenges, and covid-19-cased illness and deaths have the potential to significantly impact mental health and cause stress, anxiety, and depression. adolescents may be especially vulnerable to this situation, due to their increased vulnerability to the onset of depression and anxiety in general. one promising approach to reduce anxiety and depression in youth is a neuroscience-based mindfulness intervention training for awareness resilience and action (tara). tara is usually delivered over 12 weeks by two facilitators in groups of 10-15 adolescents in-person, and it has been shown to reduce symptoms of depression and anxiety in depressed adolescents and modify brain properties. the tara intervention can also be delivered remotely. other types of therapy delivered remotely, such as internet-based cognitive behavioral therapy, have shown comparable efficiency to face-to-face delivery. the objective of this study is to utilize an individually randomized group treatment, open-label, waitlist-controlled clinical trial to test the feasibility of tara (delivered partially over zoom) in improving the self-reported emotional well-being primary outcome (emotional problems measured with the strengths and difficulties questionnaire \[sdq\]) in healthy adolescents between the ages of 14 to 18 years old during the covid-19 pandemic. our central hypothesis is that emotional well-being of adolescents in the intervention group will improve stronger (or deteriorate less) than in the control group. we will test this hypothesis in 21 adolescents randomized to the tara intervention (partially delivered over zoom) (12 adolescents) or to the waitlist control group (9 adolescents).


Eligibility criteria:
inclusion criteria: * healthy female and male adolescents, 14-18 years old * fluency in english exclusion criteria: * subjects younger or older than 14-18 years old. * subjects who are not healthy. subjects who are taking any psychotropic medication. * mri contraindications (ferromagnetic objects on or inside the body, e.g., braces) and pregnancy. * not allowable: current mindfulness training (e.g. mbsr, mbct, dbt) and/or practice with a typically sitting meditation or yoga of 20 or more minutes two or more times per week within 60 days prior to study entry. * potential adolescent subjects with current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to the study requirements will be excluded and not allowed to enter the study. * potential subjects with an inability or unwillingness to give written informed assent or whose legal guardian/representative are unable or unwilling to give written informed consent will be excluded and not allowed to enter the study.
inoca-na a local prospective registry

Conditions: Ischemia, Myocardial; Non-Obstructive Coronary Atherosclerosis; Microcirculatory Status; Coronary Microvascular Dysfunction (CMD)

Summary: the present study has the following objectives: 1. to investigate the prevalence of inoca in patients referring for a clinically indicated coronary angiography (ca) c/o division of cardiology - federico ii university hospital; 2. to stratify in inoca endotypes patients according to the presence or absence of alternative (i.e. non obstructive cad) causes of myocardial ischemia detected during ca clinically indicated through physiology tests; 3. to implement a stratified therapy in these patients considering the different inoca endotypes and evaluate the impact on angina class and quality of life as well as cardiac hospitalization and coronary revascularization during 5 year follow up

eligible patients with angina and/or positive stress test undergoing clinical indicated ca detecting non-obstructive cad will be studied as follows: * functional evaluation by fractional flow reserve (ffr), instantaneous wave-free ratio (ifr), resting full-cycle ratio (rfr) of any stenosis that is angio- graphically considered \&gt; 50%; * in case of stenosis \&lt;50% or \&gt;50% but with negative functional evaluation (ffr \&gt;0.80 and ifr/rfr \&gt;0.90), coronary flow reserve (cfr) and index of microvascular resistance (imr) will be performed. imr and cfr will be evaluated, using an intracoro- nary wire; * in case of cfr\&gt;2.0 and imr\&lt;25, acetylcholine test will be performed. intracoronary acetylcholine (ach) will be administrated to detect epicardial (fo- cal or diffuse) or microvascular spasm.

Eligibility criteria:
inclusion criteria: * clinical presentation of chronic ischemic heart dis- ease (ihd), requiring coronary angiography for the diagnosis; * absence of obstructive coronary artery disease (cad) at coronary angiography; * age \&gt; 18 years. * ability to provide a valid informed consent to the study procedure at the time of baseline evaluation; exclusion criteria: clinical presentation of acute coronary syndrome (acs) or cardiogenic shock; * presence of obstructive cad with at least 1 significant coronary artery stenosis, defined as diameterstenosis \&gt;50% and ffr ≤0.80 (or ifr/rfr ≤0.89); * previous coronary artery bypass grafting (cabg); * left ventricular systolic dysfunction, defined as ejection fraction (ef) \&lt;40%; * severe valvular heart disease; * pregnant or breastfeeding women * known hypersensitivity or contraindication to any of the drugs used for coronary physiology testing (adenosine, nitrates, acetylcholine) * inability or unwillingness to provide a valid in- formed consent to the study procedure at the time of baseline evaluation.

Keywords: inoca cmd vsa
a study for crossability of spherical tip versus regular noncompliant balloon in tortuous coronary artery postdilatation

Conditions: Coronary Artery Disease

Summary: the goal of this clinical trial is to compare the crossability of novel spherical tip versus regular noncompliant balloon in chd population with tortuous coronary artery leisions that requiring postdilation after stent implantation. the main question it aims to answer is: •wether the spherical tip balloon have advantages in terms of crossability compared to regular noncompliant balloons participants will sign an informed consent form, collaborate with data collection, and accept the intervention measures from corresponding groups. researchers will compare spherical tip balloon with regular noncompliant balloon to see if there is any difference in crossability.

the tortuous lesion increases the difficulty of coronary intervention treatment, especially when there is still a large angle after stent implantation. the ability of the non compliant balloon to pass through the stent segment becomes the key to complete the operation. the spherical tip noncompliant balloon is an original design by our center, which reduces its resistance to stent struts through the spherical structure of balloon tip, and is committed to increasing the crossability of the balloon.this study is a multicenter, randomized, single blind design with the aim of truly revealing the differences in parameters such as success rate of crossing, times of attemptation, and time consumption between the novel spherical tip and regular non compliant balloon.

Eligibility criteria:
inclusion criteria: * over 18 years old, regardless of gender * patients with indications for coronary artery stent implantation * the vascular curvature angle\<120 ° after coronary artery stent implantation * noncompliant balloon postdilation is required * voluntarily participate and sign an informed consent form exclusion criteria: * pregnant women or patients who are attempting to get pregnant * patients participating in clinical trials of other drugs or medical devices * patients deemed unsuitable by the researchers to participate in this clinical trial

Keywords: coronary artery disease spherical tip noncompliant balloon postdilation percutaneous coronary intervention
pharmacokinetics, safety, and efficacy of intravenous dosing of buprenorphine in pediatric patients who require opioid analgesia for acute moderate to severe pain

Conditions: Other Acute Postoperative Pain; Prolonged Endotracheal Intubation

Summary: the purpose of this study is to characterize the safety, pharmacokinetics (pk), and efficacy of intravenous (iv) buprenorphine in pediatric patients.

a study of the pk, safety, and efficacy of iv buprenorphine in acute moderate to severe pain in male and female pediatric patients aged from birth to 6 years, inclusive, requiring continuous opioid analgesic treatment for at least 24 hours and up to 72 hours.

Eligibility criteria:
inclusion criteria include: * must have written informed consent provided by the parent or legal guardian and/or patient assent, when appropriate * male and female children, from birth to aged 6 years, inclusive, with minimum weight of 2.5 kg * have or are anticipated to have acute moderate to severe pain; requiring treatment with an intravenous (iv) opioid analgesic medication for at least 24 hours postoperatively or; due to prolonged endotracheal intubation requiring iv opioid analgesic treatment for at least 24 hours poststabilization * must have stable vital signs * must have stable respiratory status * must be inpatient for the treatment period of the study exclusion criteria include: * have any known allergy or sensitivity to buprenorphine or other opioids (this criterion does not include patients who have experienced common opioid side effects \[eg, nausea, constipation\]) * have evidence of impaired renal function * have hepatic impairment * have history of seizures * have a history of sleep apnea within the past year * have structural heart disease or a pacemaker * have clinically unstable cardiac disease * have used any investigational medication/therapy within 30 days prior to the first dose of study drug * are deemed to be unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria. other protocol-specific inclusion/exclusion criteria may apply.

Keywords: acute pain opioid analgesia
the effect of vestibular rehabilitation in autistic children

Conditions: Autistic Spectrum Disorder; Vestibular Disorder; Sensory Integration Disorder

Summary: this study was conducted to clarify the effect of vestibular education for autistic children on "sensory profile" and "postrotary nystagmus". in the study, the results of the two groups were compared through the treatment of sensory integration: the once who got the education and the once who did not. for this study, 26 autistic children were included who joined the " çatalca district unit of disabled the project of no disabilities ", who was diagnosed with autism, who was 3-10 years (older than 36 months younger than 11 years). for each child, the analysis of the sensory integration and nystagmus was applied twice; at the beginning and at the end of the research. at the beginning of the research, the children were divided into two groups randomly drawn by lots. the first group was given the education of sensory integration with vestibular education and the second group was given the education of sensory integration without vestibular education. both groups were educated for 10 weeks, 2 days a week with 40- minute sessions.


Eligibility criteria:
inclusion criteria: * the study included autistic children aged between 3 and 10 years (36 months, 11 years old) who were diagnosed with autism according to the diagnostic and statistical manual of mental disorders criteria. the families of all children who participated in the study were informed and their written permissions were obtained. exclusion criteria: * children who were not diagnosed with autism and who had previously received treatment for sensory integrity were excluded. the children who participated in the study had independent walking problems, those with lack of extremity, those with hip dislocation, those with postural anomalies, those who had an operation, those with infectious diseases, those with additional diagnoses with autism (such as cerebral palsy), patients with seizures, traumatic postpartum trauma, and motor development disorder. those with the postural disorder were not included in the study