Kornimate/medical-research-clean huggingface dataset:
tr(ace) assay clinical specimen study

Conditions: Carcinoma, Non-Small-Cell Lung; Breast Neoplasms

Summary: the tr(ace) assay is a quantitative in vitro diagnostic test run on the tr(ace) instrument intended for the measurement of high molecular weight human dna from plasma as an aid to monitoring disease progression or response to therapy or recurrent or residual disease.

this study is to establish the clinical performance of the tr(ace) assay. deltas of serial tr(ace) assay measurements will be compared to the standard of care physician clinical assessment and recist 1.1 criteria evaluation relative to the previous visit. significant changes in serial tr(ace) assay measurements are hypothesized to correlate with disease progression or response.

Eligibility criteria:
inclusion criteria: * non-small cell lung: male or female adult patient \>= 21 years old * breast only: female adult patient \>= 21 years old * previously diagnosed with one of the following cancers: breast or non-small cell lung * cancer has progressed to at least stage iii or higher for lung cancer or, * cancer has progressed to stage iv (metastatic) breast cancer * participating in standard of care cancer therapy requiring frequent treatments, typically intravenous chemotherapy visits (or as determined by the standard of care for the particular cancer assessed), of a minimum of three (3) treatment visits planned in 9 months from date of enrollment where a clinical assessment will be conducted exclusion criteria: * physician assessment that obtaining two extra whole blood specimens with minimum volume of 5 ml per treatment visit is contraindicated * stage i and ii non-small cell lung cancer * stage i through iii breast cancer * pregnant or planning to become pregnant during the course of the study * unable to obtain informed consent from subject or their legal representative * life expectancy is less than 9 months * presence of one or more of the following other chronic diseases * another type of cancer except for non-melanomatous skin tumors * autoimmune disease requiring dmards or biologics * infectious disease requiring prolonged intravenous antibiotics or hospitalization * renal disease specifically those in end stage renal failure * recent (\< 3 weeks) major trauma or major surgical procedure(s) or radiation therapy prior to enrollment in the study * recent (\< 2 months) major occlusive arterial event such as mi or cva prior to enrollment in the study

Keywords: lung cancer breast cancer cell free dna biomarker
alteration of thrombelastography and coagulation function in patients undergoing total knee arthroplasty with intra-articular tranexamic acid administration

Conditions: Arthropathy of Knee

Summary: the main aim and scope of this study is making comparison about the thrombelastography and coagulation function in patients before and after the total knee arthroplasty with intra-articular tranexamic acid administration. the results may identify the influence of the intra-articular tranexamic acid administration on the relative coagulability monitoring.


Eligibility criteria:
inclusion criteria: * the patients received primary total knee arthroplasty; * normal pre-operative coagulation function; * complete surgery document, transfusion document and relative blood test. exclusion criteria: * the patients received complicated total knee arthroplasty; * abnormal pre-operative coagulation function caused by some diseases such as hepatic inadequacy, thrombocytopenia et al. * incomplete documents.

Keywords: total knee arthroplasty thrombelastography coagulation function
empagliflozin in heart failure: diuretic and cardio-renal effects

Conditions: Heart Failure; Type II; Diabetes

Summary: the investigators propose a small pilot proof of concept study to not only prove the existence of, but also probe the mechanisms underlying cardio-renal effects of empagliflozin in patients with heart failure. the investigators propose a 50 patient randomized, double-blind, placebo-controlled crossover study with patients with stable hf, type ii diabetes and an egfr \>45ml/min/1.73 m2 who are chronically receiving loop diuretics.

study objectives 1. study the acute/short term effect and cardio-renal mechanisms of sodium-glucose cotransporter 2 (sglt2) inhibition in patients with heart failure. 2. determine the effect of chronic combined sllgt2 and loop diuretic exposure in patients with heart failure. primary outcomes 1. aim 1 (acute): determine if acute sglt2 inhibition will improve the natriuretic effect of a loop diuretic compared to placebo. 2. aim 2 (chronic): determine the effect of 14 days of sglt2 inhibition on blood volume.

Eligibility criteria:
inclusion criteria: * stable hf as defined by: * no hospitalization for \>60 days * stable hf medications for \>=2 weeks, and stable diuretics for 4 weeks * opinion of hf cardiologist that the patient is at their optimal volume status * chronic daily oral loop diuretic dose \>=20mg furosemide equivalents * diagnosis of type ii diabetes * patient monitors blood glucose regularly at home * egfr \>=45 ml/min/1.73 m2 * \>=18 years old exclusion criteria: * active titration of chronic hf medications expected during the study period * use of a non-loop diuretic, aside from an aldosterone antagonist (\<=25mg spironolactone or \<=50mg eplerenone) * critical stenotic valvular disease, complex congenital heart disease, or prior heart transplant * history of diabetic ketoacidosis, "brittle" diabetes, and/or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (er visit or ems response, glucagon administration or forced oral carbs) in the last 6 months * history of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections * anemia (defined as hemoglobin \<8g/dl) * pregnancy or breastfeeding * history of serious hypersensitivity * participation in another trial with an investigational drug within the 30 days prior to informed consent * use of another sglt-2 inhibitor * appears unlikely, or unable to participate in the required study procedures, as assessed by the study pi or research rn (ex: clinically-significant psychiatric, addictive, or neurological disease) * inability to give written informed consent or follow study protocol

Keywords: cardio-renal
comparison of in-house methods and cobas braf v600 mutation assay in melanoma tumor samples

Conditions: Malignant Melanoma

Summary: this non-interventional study will compare the cobas braf v600 mutation assay with in-house methods used in molecular laboratories for the assessment of the braf mutation status in melanoma tumor samples. no patients will be enrolled in this study. data will be collected for approximately 6 months.


Eligibility criteria:
inclusion criteria: no patients are enrolled. use of tumor samples only. * histologically proven melanoma tumor sample * any type of tumor sample: biopsy or surgical specimen of primary tumor or metastasis * tumor samples must be fixed and paraffin-embedded. exclusion criteria: no patients are enrolled. use of tumor samples only. * fixative unknown
oral immunotherapy for peanut and mammalian meat allergies

Conditions: Food Hypersensitivity

Summary: pilot study to assess the effect of oral immunotherapy on specific immunoglobulin e (ige) levels and antigen consumption in two distinct food allergies.

in subjects with mammalian meat allergy, the effect of daily oral cow's milk on immune parameters and desensitization will be assessed. similarly, in subjects with a peanut allergy the effects of low dose peanut flour will be assessed and comparisons between two distinct food allergies.

Eligibility criteria:
inclusion criteria: * presence or absence of specific ige to alpha-gal or peanut exclusion criteria: * history of severe anaphylaxis * allergy to cow's milk protein
the safety and efficacy of thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery for the treatment of hypertrophic scars and keloids

Conditions: Keloid

Summary: this study aims to assess the safety and efficacy of thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery for the treatment of hypertrophic scars and keloids.


Eligibility criteria:
inclusion criteria: * healthy volunteers without underlying disease * patient with keloid age more than 6 months and keloid thickness more than 1 mm. exclusion criteria: * dermatitis or infection on treatment area * suspected cancer on treatment area * immunocompromised host * pregnancy or lactating woman * recieved corticosteroid injection within 2 months

Keywords: keloid, thermo-mechanical system
the alaska oculocardiac reflex study

Conditions: Bradycardia; Strabismus

Summary: observation study monitoring vital signs and anesthetic variables particularly heart rate during prospective, ocular manipulation and specifically uniform tension on extra ocular muscles during strabismus surgery. \*irb approval from 1992 covered in letter from then irb chair dr. judith whitcomb, anchorage, alaska (letter 10/2020).\*

patients with ocular manipulation including those scheduled for strabismus surgery will have peri-operative variables monitored before, during and after uniform traction on extra ocular muscles (eom). the oculocardiac reflex (ocr) will be elicited by quantified (200 gram, 10-second, square-wave) traction on jameson muscle hook under insertion of an extra ocular muscle (eom, rectus). stable pre-tension heart rate, and greatest change heart rate will be recorded. additional variables to be recorded: birthdate, gender, race, weight, iris color, pre-operative neurodevelopmental conditions, pre-operative medications, induction medications, expired carbon dioxide (co2) levels, exhaled gas concentrations, anticholinergic medications, opioids, muscle relaxants, type of airway and the number of eom operated.

Eligibility criteria:
inclusion criteria: * patient scheduled for ocular manipulation and tension on extra ocular muscles and strabismus surgery exclusion criteria: * anophthalmia

Keywords: oculocardiac reflex
bioavailability study of pf-06651600 in healthy subjects

Conditions: Healthy

Summary: pf-06651600 is being developed for treatment of inflammatory bowel disease. this study will test the bioavailability of a solid dose formulation of pf-06651600 compared to an oral solution formulation under fasting conditions and the effect of a high fat meal on the bioavailability of the solid dose formulation of pf-06651600 in healthy subjects. safety and tolerability of the tablet and oral solution formulations of pf-06651600 will be assessed under fasting and fed conditions.


Eligibility criteria:
inclusion criteria: * healthy male/female subjects between 18 and 55 years old, inclusive. females must be of non-child bearing potential. * bmi of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * prior history of chicken pox. * evidence of personally signed and dated informed consent document. * willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gi, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males. * screening blood pressure \>140/90 mm hg. * screening laboratory abnormalities as defined by the protocol. * unwilling or unable to comply with the lifestyle guidelines as defined by the protocol.

Keywords: inflammatory bowel disease
effect of virtual reality distraction on anxiety control during impacted molar tooth surgery

Conditions: Dental Anxiety; Impact Molar; Virtual Reality

Summary: the goal of this clinical trial is to investigate the effectiveness of virtual reality distraction therapy using virtual reality glasses in reducing dental anxiety during the surgical extraction of impacted lower third molar teeth.the main questions it aims to answer are: * is the use of the virtual reality distraction during the procedure effective on perceived pain and anxiety? * evaluation of the effectiveness of the virtual reality distraction based on initial anxiety test scores. * does the use of the virtual reality headset cause difficulties for the clinician in performing the procedure? patients will undergo anxiety tests before surgery. pre-operative vital signs will be recorded. the procedure will be performed either with or without virtual reality glasses, according to the randomly assigned groups. post-operative vital signs will be recorded. at the end of the procedure, all patients will undergo anxiety tests and verbal rating scales.


Eligibility criteria:
inclusion criteria: * being over 18 years old * being systemically healthy * needing surgical extraction treatment of impacted lower third molar (in mesioangular position according to tetsch and wagner classification) * having a score of 11 or higher on the dental anxiety scale exclusion criteria: * history of seizures or convulsive disorders * balance disorders such as nystagmus or vertigo * use of psychotropic medications * undergoing treatment for anxiety * patients with psychiatric disorders * presence of dermatological lesions, especially around the face and eyes * presence of any lesion in the eye that would prevent the use of virtual reality * presence of systemic diseases and medication use contraindicating surgical extraction of impacted teeth

Keywords: dental anxiety impact molar virtual reality
pnf with and without ems on spasticity, gait and lower limb function in chronic stroke patients

Conditions: Chronic Stroke

Summary: the main purpose of conducting this study is to decrease the tone through pnf techniques and ems application. by decreasing the tone, spasticity may be reduced in stroke patients and may inturn lead to better approaches to treat those patients. so, the findings of this study can help in formulation of future guidelines for management of stroke that will help the clinicians to treat such patients in more efficient way..

a rct that investigated the effects of pnf interventions in patients of chronic stroke using balance and gait as outcome measures. 19 studies with 532 participants were included, of which 12 studies with 327 participants were included for meta-analysis. when data was pooled, pnf made significantly improvement in balance and gait of chronic stroke patients. this review indicates that pnf is a potential treatment strategy in chronic stroke rehabilitation on balance and gait. a systematic review to investigate the effects of proprioceptive neuromuscular facilitation (pnf) on spasticity post-stroke. six studies were included in this systematic review. three were pilot studies, clinical controlled trials, and randomized controlled trials. the findings of this study showed evidence on the benefits of the pnf intervention on spasticity post-stroke. a study is to identify the effectiveness of proprioceptive neuromuscular facilitation (pnf) leg kinesio taping on gait parameters and dynamic balance in chronic stroke patients with foot drop. a total 22 chronic stroke patients were randomly assigned to experimental and control groups. all subjects underwent conventional therapy and gait training for 50 mints. all of the measurements were performed baseline and 24 h after intervention. the results of this study yields that the short-term effect of application of lower-leg kt according to the pnf pattern increased the gait ability and dynamic balance of chronic stroke patients with foot drop. gap: as it is evident from the literature that pnf and ems has beneficial effects in the treatment of chronic stroke patients and little work has been done on seeing the mechanism of its effects on upper limb of chronic stroke patients. but up to the researcher's knowledge least work has been done on seeing its effects in specifically lower limb and gait of stroke patients. so, in this study the effects of pnf with and without ems will be documented in the lower limb of stroke patients in terms of spasticity and their gait.

Eligibility criteria:
inclusion criteria: * age 50-65 years old * both male and female patients * glasgow coma scale(gcs) score more than 10 * mini mental scale examination score(mmse) more than 18 * patient with mmt grade 3+ exclusion criteria: * demyelinating diseases. * trumatic head injury * psychological or psychiatric disorder * myopathies, peripheral nerve injury * tumors * recent fractures * visual, hearing deficits * any history of fall * seizures. * cardiac issues.

Keywords: electrical muscle stimulation proprioceptive neuromuscular facilitation physiotherapy spasticity stroke
superiority of glimepiride over sitagliptin in naive type 2 diabetes patients

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: to determine the superiority of glimepiride over sitagliptin in the reduction of hba1c after 6 months of treatment in patients with monotherapy until the end of the trial. secondary objective: to evaluate the effect of glimepiride compared to sitagliptin in: glucose in fasting conditions; postprandial glucose; percentage of patients with hba1c \< 7% and \< 6.5%; symptomatic hypoglycemia; body weight; percentage of withdrawal and percentage of patients with rescue therapy; safety (adverse events and serious adverse events, hypoglycemia, vital signs and laboratory results).


Eligibility criteria:
inclusion criteria: * subject naïve to treatment * hba1c \> 8.5 up to 11 % * lipid lowering therapy, antihypertensive, hormonal substitutes, thyroid hormone substitutes, and contraceptives are allowed as long as they are kept at a stable dosing exclusion criteria: * treatment with any oral antidiabetics or insulin * known type 1 diabetes mellitus * pregnant or breast feeding women * ketoacidosis history * history of sensitivity to any of the active substances * renal dysfunction : serum creatinine \> or = 1.5 mg/dl in male subjects \> or = 1.4 mg/dl in female subjects * liver impairment (alt, ast \> 3-fold the upper limit of normal range) * systemic corticosteroid treatment 3 months prior to study or during the study * drug or alcohol abuse history * patients with history of acute coronary syndrome, cerebrovascular events/transient ischaemic attack in the last three months * presence of any condition (medical, psychological, social or geographic) current or previously seen that according to investigators judgment jeopardizes the safety or restricts the participation of the patient during the study * neoplasias the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
multimodal program for cancer related cachexia prevention

Conditions: Neoplasms; Cancer; Cachexia; Malnutrition; Educational Problems

Summary: the aim of the study is to evaluate the effectiveness of a multifactorial education and support program for the prevention of cancer-related cachexia syndrome, for patients and their family caregivers during anti-cancer treatment.

after being informed about the study and the need to nominate a family caregiver, all patients and their family caregiver giving written informed consent, they will undergo a 12-weeks multimodal program. randomly they will divided into two groups (intervention and control). this 12-weeks multimodal program includes 4 meetings (with cancer nurse and clinical dietician). in this 4 meetings (about 30 minutes) they will have blood tests (crp, albumin levels), body composition measurements, questionnaires, education on their diet and symptom management.

Eligibility criteria:
inclusion criteria: 1. 18 years old or older 2. participants must be diagnosed with solid tumour (stomach, colorectal, pancreas, breast, lung) 3. participants needing chemotherapy/immunotherapy/hormone therapy/target therapy 4. participants must be normal or pre cachectic as defined by the guidelines 5. read and understand greek or english exclusion criteria: 1. haematologic tumors 2. parenteral nutrition 3. ecog performance status \>2 or karnofsky performance status \<60% 4. participant who can not introduce a family caregiver 5. participants in cachexia or refractory cachexia stage as defined by the guidelines below: * \>5% weight loss over the past 6 months (in absence of simple starvation); or * bmi \ 2%; or * appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men \ 2% 6. patients who use complementary therapies (ex-acupuncture)

Keywords: cachexia prevention management malnutrition
inflammatory markers in exhaled breath (condensate) in childhood asthma

Conditions: Asthma; Healthy; Children

Summary: background: exhaled nitric oxide and inflammatory biomarkers in exhaled breath condensate may be useful to diagnose and monitor childhood asthma. their ability to indicate an asthma diagnosis, and to assess asthma severity and control, is largely unknown. objective: to study 1) the ability of exhaled nitric oxide and inflammatory markers in exhaled breath condensate (nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor necrosis factor-α, interleukin-2,-4,-5,-10, acidity) to discriminate between childhood asthma and controls. 2) the ability of these biomarkers to indicate asthma severity and control. methods: 114 children were included: 64 asthmatics (10.7±3.0 years, 67.2% atopic) and 50 controls (10.0±0.4 years). condensate was collected using a glass condenser


Eligibility criteria:
inclusion criteria: * asthmatic and control children, aged 5 to 16 years * children with doctor-diagnosed asthma, known at the department of paediatric pulmonology, university hospital maastricht exclusion criteria: * presence of a disease that might interfere with the results of this study (e.g. recent upper airway infection, heart disease, anatomic abnormalities of the airways and other chronic inflammatory diseases such as crohns disease and rheumatoid arthritis) * mental retardation * inability to perform the ebc procedure properly * active smoking * the use of one of the following medication: papaverin, sodium nitroprusside, ace inhibitors, oxymetazoline, l-arginine, or nos inhibitors

Keywords: inflammometry exhaled breath condensate fractional exhaled nitric oxide asthma children