Kornimate/medical-research-clean huggingface dataset:
the effectiveness of a thyme and honey spray for oral toxicities

Conditions: Cancer of the Head and Neck; Xerostomia; Oral Mucositis; Radiation Toxicity

Summary: aim: to evaluate the effectiveness of thymus honey on radiation induced-oral mucositis and xerostomia. background: oral mucositis and xerostomia are two of the most severe side effects that head and neck cancer patients confront during and after the completion of radiotherapy. although several medications are used for their treatment, these fail to provide a fully effective and comprehensive management. honey and thyme have been studied for the management of various treatment-related side effects. design: α double blinded randomised controlled trial will be used for this study. methods: 200 head and neck cancer patients who receive radiotherapy will be included in this study. patients will be randomised and divided into two equal groups of 100 participants; the intervention group (oral spray with thyme and honey + standard care) and the control group ( placebo spray + standard care). assessments with xerostomia and oral mucositis scales additionally to 4 self-administered questionnaires will occur in both groups at baseline and then weekly and 6 months following completion of treatment. the duration of the study will be 3 years from the day of approval of this research protocol.


Eligibility criteria:
inclusion criteria: * patients with a confirmed histologic diagnosis of head and neck cancer * patients referred to non-palliative radiotherapy to the oral cavity will be included in the study * synchronous or induction chemotherapy, or both, will be permitted. * patients aged over 18, * patients able to provide informed consent, * patients having radiotherapy for at least three weeks (lower limit has been set at 50 gy), * patients able to complete records accurately exclusion criteria: * patients with a confirmed and medically treated diabetes mellitus, * patients with allergy to honey, thyme or any other ingredient, * patients who will refuse to take part in this study and * patients with previous radiotherapy or presence of systemic disease.
influence of molecular abnormalities on response of vah vs. ven+hma in rr-aml

Conditions: Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; Gene Abnormality; Cytogenetic Abnormality

Summary: the aim of this study is to reveal the influence of gene mutations on the treatment response of the regimen of hht combined with venetoclax plus aza versus venetoclax plus hma in the salvage therapy of rr-aml.

venetoclax-based regimens have heen used in the salvage therapy of relapsed/resfractory (rr) acute myeloid leukemia (aml). more and more studies have shown that molecular abnormalities and venetoclax combined regimens significantly impact the response of venetoclax-based therapy. our exploratory study revealed that venetoclax plus azacytidine combined with homoharringtonine (vah) had remarkably higher response than venetoclax plus hypomethylating agents (hma) in rr-aml. yet the influence of molecular abnormalities on the response of vah regimen remains unknown.

Eligibility criteria:
inclusion criteria: 1. rr-aml 2. patients must have been treated for at least one cycle of ven-based regimen and finished outcome assessment. exclusion criteria: 1. acute promyelocytic leukemia (aml subtype m3) 2. previous exposure to the treatment of ven-based regimen 3. cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy) 4. respiratory failure (pao2 ≤60mmhg) 5. hepatic abnormalities (total bilirubin ≥2 times the upper limit of normal \[uln\], alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥2 times the uln) 6. renal dysfunction (creatinine ≥2 times the uln or creatinine clearance rate \< 30 ml/min) 7. ecog performance status 3, 4 or 5 8. substantial history of neurological, psychiatric, endocrine, metabolic, immunological, or any other medical condition not suitable for the trial (investigators' decision) 9. active acute or chronic graft-versus-host disease (gvhd). active acute gvhd or chronic gvhd is defined as gvhd requiring either at least 1 mg/kg per day of prednisone (or equivalent) or treatment beyond systemic corticosteroids. 10. patients with pregnancy 11. uncontrolled active infection 12. clinically significant coagulation abnormalities

Keywords: acute myeloid leukemia relapsed/refractory gene mutation venetoclax homoharringtonine
obesity, iron regulation and colorectal cancer risk

Conditions: Colon Inflammation; Iron Malabsorption; Obesity; Diet Modification

Summary: obesity is an independent risk factor for colorectal cancer (crc) although the underlying mechanisms have not been elucidated. dietary nutrients play a key role in both the prevention and promotion of crc. while iron is an essential nutrient, excess iron is associated with carcinogenesis. unlike the systemic compartment, the intestinal lumen lacks an efficient system to regulate iron. in conditions when dietary iron malabsorption and intestinal inflammation co-exist, greater luminal iron is associated with increased intestinal inflammation and a shift in the gut microbiota to more pro-inflammatory strains. however, treatments designed to reduce luminal, including diet restriction and chelation, are associated with lower intestinal inflammation and the colonization of protective gut microbes. obesity is associated with inflammation-induced, hepcidin-mediated, iron metabolism dysfunction characterized by iron deficiency and dietary iron malabsorption. obesity is also linked to intestinal inflammation. currently, there is a fundamental gap in understanding how altered iron metabolism impacts crc risk in obesity. the investigator's objective is to conduct a crossover controlled feeding trial of: 1) a "typical american" diet with "high" heme/non-heme iron", 2) a "typical american" diet with "low" iron, and 3) a mediterranean diet with "high" non heme iron and examine effects on colonic and systemic inflammation and the gut microbiome.


Eligibility criteria:
inclusion criteria: * self-identify as hispanic, african american, or caucasian. * meet body mass index (bmi \> = 30.0 kg/m2) and c-reactive protein (crp) criteria (\> 2.0 mg/dl) * post-menopausal (no menstruation in the past 12 months) * weight stable (\< 3% weight change in the past 3 months) * non-smoker * no major medical problems * have a working phone * no known allergies, intolerance, medical, secular or religious dietary restrictions exclusion criteria: * chronic constipation (less than three stools per week for several months) * history or intestinal cancer, inflammatory bowel disease, celiac disease, or malabsorptive bariatric surgery * previous intestinal surgery * h pylori infection or taking h2 blockers (e.g., zantac, pepcid) /antacids (e.g., rolaids) more than 3 times per week * significant blood loss or blood donation in past 3 months * active gastrointestinal bleed * any surgery in the past 3 months * hemochromatosis * sickle cell disease * hereditary polyposis * rheumatoid arthritis * type i or type ii diabetes * smoker * antibiotic use in the past 2 months * excessive alcohol consumption \[\> 2 standard alcoholic drinks (12 ounces of beer, 5 ounces of wine, 1 shot of hard liquor) per day\] * aspirin use \>81 mg/day or \>325 mg/every other day * regularly taking probiotics, fiber supplements, orlistat (over the counter brand name: alli), or steroids (inhaled or oral)
a study of ly3298176 (tirzepatide) for the maintenance of body weight reduction in participants who have obesity or overweight with weight-related comorbidities

Conditions: Overweight; Obesity

Summary: the main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.

all enrolled participants will complete a 60-week open-label weight-loss period on tirzepatide maximum tolerated dose (mtd) and upon meeting randomization criteria will enter a 52-week double-blinded weight maintenance period to be assigned to either tirzepatide 5 mg, tirzepatide mtd or placebo.

Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities: * hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease * have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (bw) exclusion criteria: * have type 1 diabetes (t1d) or type 2 diabetes (t2d), a history of ketoacidosis, or hyperosmolar state or coma. * have a self-reported change in bw\>5 kilogram (kg) within 3 months prior to screening * have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed \>1 year prior to screening. * have a history of chronic or acute pancreatitis * have any of the following cardiovascular conditions within 3 months prior to week 0. * acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, and hospitalization due to congestive heart failure (chf) * family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men-2) * history of significant active or unstable major depressive disorder (mdd) or other severe psychiatric disorder within the last 2 years * any lifetime history of a suicide attempt
investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite

Conditions: Hepatic Impairment; Hepatic Insufficiency; Healthy Subjects

Summary: this study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.


Eligibility criteria:
inclusion criteria * women must be of non childbearing status * understands the study procedures in the icf and be willing and able to comply with the protocol. * willingness and ability to swallow study drug capsule. * adult men or women, 18 to 75 years of age hepatic-impaired subjects only: * subject has a diagnosis of chronic, stable hi. * subject's score on the child-pugh scale must range from 10 to 15 at screening. exclusion criteria * history or presence of clinically significant or unstable medical or psychiatric condition or disease in the opinion of the pi. * dosed in another clinical trial within 28 days before dosing of study drug and throughout the current study. * history or presence of drug abuse within 2 years before screening.

Keywords: hepatic acalabrutinib
plasma hepcidin response to differently dosed iron supplements

Conditions: Iron Deficiency (Without Anemia)

Summary: the study participants will take 3 different doses of iron supplements at 8 am, on 3 different days. by taking blood samples in the morning and afternoon, the investigators will determine the effects of the iron supplements on plasma hepcidin and compare them to baseline plasma hepcidin values.

15 healthy young women with non-anemic iron deficiency will participate in the study. on 4 different days the investigators will take two blood samples (one in the morning at 8 am, before the iron intake and one in the afternoon at 4 pm) to determine the plasma hepcidin level. the intake of the iron supplements will be at least 48 hours apart from each other, to exclude any impacts of the previous iron intake to the next measurement. the participants will take the iron supplement supervised at 8 am after overnight fasting. all blood samples will be performed for analysis of crp and hepcidin. the investigators will measure the crp in the blood sample to exclude any impacts of inflammation to the hepcidin measurement and use a crp ≤5mg/l as a cut-off. if the crp is higher than 5mg/l the investigators will exclude the measurement from our analyses and repeat the measurement at another day. the first two blood samples will be taken at 8 am and at 4 pm on the same day and after overnight fasting to find the baseline hepcidin, the other blood samples will be taken at 8 am before the iron intake and at 4 pm also on the same day and also after overnight fasting.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * female gender * premenopausal * age \> 18 years * regular menstrual cycle * bmi in normal range (18-25kg/m2) * serum-ferritin ≤30ng/ml * no anemia * no intake of dietary supplements exclusion criteria: * intake of dietary supplements * pregnancy * hypermenorrhea (\> 80ml blood loss, or more than 5 unties/tampons per day) * anemia * serum-ferritin \>30ng/ml * bmi \ 25 kg/m2 * chronic inflammatory disease * hypersensitivity to iron supplements
mitochondrial derived reactive oxygen species on cardiovascular health in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: cardiovascular health is a critical problem in patients with chronic obstructive pulmonary disease (copd). existing literature suggests oxidative stress from the mitochondria c driving some of the poor health outcomes in copd. mitoq is a mitochondrial-targeted antioxidant that has shown promise in improving cardiovascular outcomes in similar populations. thus the purpose of this study is to test if mitoq can improve cardiovascular health in copd.

in this study, a mitochondria-specific antioxidant will be compared to a placebo. participants will be assigned randomly to receive either the antioxidant or the placebo for 6 weeks. a comprehensive assessment of cardiovascular health will be conducted before and after the administration of the supplement.

Eligibility criteria:
inclusion criteria: * clinically diagnosed of copd * global initiative for obstructive lung disease (gold) stages ii to iv exclusion criteria: * forced expiratory volume in 1 second/ functional vital capacity (fev1/fvc) \>0.7 * heart disease * diabetes * vasoactive medications * uncontrolled high blood pressure * fluid in lungs * sleep apnea * raynaud's phenomenon * gangrene of the digits * history of coagulation * pregnant women * children

Keywords: mitoq vascular function cardiovascular health exercise intolerance mitochondria
efficacy and safety of ui05msp015ct in functional dyspepsia

Conditions: Functional Dyspepsia

Summary: this study is a multi-center, randomized, active-controlled, double-blind, non-inferiority, phase iii clinical trial evaluating efficacy and safety of once-daily mosapride (ui05msp015ct) in patients with functional dyspepsia.

patients with functional dyspepsia were randomly assigned (1:1) to receive either ui05msp015ct (15 mg once daily before breakfast, study group) or mosapride (5 mg three times a day before each meal, control group) and corresponding placebo t.i.d. or q.d. for 4 weeks.

Eligibility criteria:
inclusion criteria: 1. age \>19 years 2. diagnosis of functional dyspepsia meeting rome iii criteria 3. at least three moderate or severe symptoms included in the symptom score 4. no structural lesions of upper gastrointestinal tract exclusion criteria: 1. history of dyspepsia unrelated to functional dyspepsia or diseases 2. history of gastrointestinal surgery 3. history of malignancy in the previous 5 years 4. psychiatric disorders including major depressive disorder and anxiety 5. liver cirrhosis or abnormal liver laboratory findings 6. advanced chronic kidney disease 7. uncontrolled hypertension 8. uncontrolled diabetes 9. pregnancy and lactation 10. recent history of taking medication affecting the gastrointestinal system
role of novel ilr in the management of pvcs

Conditions: PVC - Premature Ventricular Contraction; Myocarditis

Summary: this prospective, observational study is a single center clinical registry of patients referred for management of symptomatic or asymptomatic premature ventricular contractions (pvcs). subjects will be followed through 12 months. the study will enroll approximately 50 patients.

this study is intended to monitor patients presenting with premature ventricular contractions (pvcs) and ventricular arrhythmias using implantable loop recorders (ilrs) from the time of their initial presentation of pvcs to assess for the incidence of all cardiac arrhythmias detected with long term monitoring in this population. it is also intended to evaluate for clinical, biomarker and radiological evidence of myocarditis in this cohort to understand association with incident arrhythmias and understand the role of implantable loop recorders (ilrs)in managing these patients.

Eligibility criteria:
inclusion criteria: * patients \> 18 years of age * have a medtronic linq ii ilr * willing and able to give written informed consent exclusion criteria: * history of myocardial infarction * significant flow-limiting coronary artery disease (≥50% stenosis) on invasive coronary angiography or computed tomography angiography (cta). * history of cardiac arrest * with existing implantable defibrillators * currently pregnant
efficacy, safety, and tolerability of sr750 in patients with trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: the goal of this clinical trial is to evaluate the efficacy，safety and tolerability of sr750 in patients with trigeminal neuralgia (tn). patients will receive sr750 (study drug) or placebo for 6 weeks and keep a diary of daily pain. the study duration for each patient is up to 11 weeks.

this is a phase 2, randomized, double-blind study comparing sr750 with placebo in patients with trigeminal neuralgia. it consists of a screening period, a double-blind treatment period, and a post-treatment safety follow-up period. baseline pain intensity and number of paroxysms will be taken in the run-in period of screening period and will be checked for eligibility. around 162 eligible subjects will be recruited and randomized into three arms at 1:1:1 ratio to receive sr750 high dose twice a day (bid) , sr750 low dose bid or placebo bid for 6 weeks. subjects, investigators, all clinical study site staffs, and the sponsor will remain blinded to treatment assignment during the study. subjects will be asked to record the number of paroxysms of pain, severity of daily average pain of paroxysms and severity of daily worst pain in e-diary over the last 24 hours every night before going to bed. after completion of double-blind period, subjects will continue to complete the safety follow-up.

Eligibility criteria:
key inclusion criteria: * diagnosis of trigeminal neuralgia as per international classification of headache disorders third version (ichd-3) criteria for at least 3 months prior to screening * subjects must have completed at least 5 daily pain score and experienced ≥3 paroxysms per day with a daily average pain sore of ≥4 on pi-nrs during the seven days of run-in period. * willing and able to undergo washout of prohibited medication as per protocol requirements and refrain from use of the prohibited medication throughout the study period. * female subjects must be non-pregnant and non-lactating. key exclusion criteria: * secondary trigeminal neuralgia * painful trigeminal neuropathies * other pains that cannot be clearly differentiated from the pain associated with tn or may interfere with the pain assessment * subjects have previously undergone microvascular decompression (mvd), sensory rhizotomy of trigeminal nerve, radiofrequency ablation (rfa), percutaneous balloon compression (pbc), permanent lesion of trigeminal semilunar ganglion, botulinum toxin type a for the treatment of tn within 6 months prior to screening. subjects with severe complication after therapeutic procedure would also be excluded. * known history of human immunodeficiency virus (hiv) or active infection of hepatitis b virus (hbv), hepatitis c virus (hcv) or treponema pallidum

Keywords: trigeminal neuralgia sr750
study of an investigational nasal aerosol or placebo in children (ages 4 to 11) with perennial allergic rhinitis (par)

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to evaluate the efficacy and safety of beclomethasone dipropionate (bdp) nasal aerosol in subjects with perennial allergic rhinitis (par).


Eligibility criteria:
inclusion criteria: * male or female subjects 4 to 11 years of age, inclusive, as of the screening visit (sv). * a documented history of par to a relevant perennial allergen for a minimum of 12 months (6 months for subjects 4 to 5 years of age) immediately preceding the study screening visit (sv). * a demonstrated sensitivity to at least one allergen known to induce par through a standard skin prick test. * other criteria apply. exclusion criteria: * history of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (e.g., nasal piercing) or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the screening visit \[sv\]). * history of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis or influenza) within the 14 days preceding the screening visit (sv), or development of a respiratory infection during the run-in period. * active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drug (e.g., theophylline, leukotriene antagonists). history of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the screening visit (sv) is acceptable. * have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial. * other criteria apply.

Keywords: allergic rhinitis pediatric subjects bdp nasal aerosol
effect of myofascial release on dysphagia in stroke survivors

Conditions: Dysphagia

Summary: the goal of this clinical trial is to explore clinical effect of myofascial release therapy in dysphagic stroke survivors. the main question it aims to answer is: • can myofascial release therapy improve swallowing function in stroke survivors? patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given myofascial release therapy. the study lasts 21 days for each patient. researchers will compare the functional oral intake scale, penetration-aspiration scale, swallowing quality of life to see if the myofascial release therapy can help improve the situation.

myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. it involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation. the goal of this clinical trial is to explore clinical effect of myofascial release therapy in dysphagic stroke survivors. the main question it aims to answer is: • can myofascial release therapy improve swallowing function in stroke survivors? patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given myofascial release therapy. the study lasts 21 days for each patient. researchers will compare the functional oral intake scale, penetration-aspiration scale, swallowing quality of life to see if the myofascial release therapy can help improve the situation.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * meeting the diagnostic criteria of stroke; * any degree of dysphagia at admission; * steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment. * transferred out within three weeks of hospitalization in the neurology department. exclusion criteria: * complicated with other neurological diseases; * damaged mucosa or incomplete structure in nasopharynx; * tracheostomy tube plugged; * unfeasible to myofascial release; * simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.